News & Events

Inventiva announces that FDA lifts target class clinical hold which allows long-term clinical studies with lanifibranor in NASH

Inventiva announces that FDA lifts target class clinical hold which allows long-term clinical studies with lanifibranor in NASH

May 23, 2019

Daix (France), May 23, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced that the U.S. Food and Drug Administration (FDA) has lifted for lanifibranor the clinical hold in place on the peroxisome proliferator-activated receptor (PPAR) target class. This decision enables Inventiva to conduct clinical trials equal to or longer than six months evaluating lanifibranor for the treatment of NASH. This authorization follows the review of the drug candidate’s two-year carcinogenicity studies by the FDA’s Executive Carcinogenicity Assessment Committee (ECAC).

The FDA decision, which confirms lanifibranor’s benign safety profile, represents a key milestone for Inventiva as it removes a key obstacle preventing the Company from initiating the long-term Phase III clinical trials necessary to obtain marketing approval for the drug candidate for the treatment of NASH.

Some single PPAR and dual PPAR agonists have been associated with toxicity and adverse effects on the heart, kidney, skeletal muscle and bladder, as well as on body weight, water retention and bone mineral density. As a result, FDA regulations regarding the PPAR class of compounds require two-year carcinogenicity and one-year in vivo toxicity studies to be performed prior to a product candidate entering clinical trials longer than six months. In accordance with these requirements, Inventiva launched three long-term toxicological studies of lanifibranor in 2015. Inventiva first evaluated lanifibranor in a 12-month primate toxicological study, in which the administration of the drug candidate was not associated, at any dose-level tested, with the toxicity and adverse effects linked to single and dual PPAR agonists. In parallel, lanifibranor was evaluated in two 2-year carcinogenicity studies in rats and mice designed to identify any potential carcinogenic risk. In these two studies, lanifibranor was not associated with any carcinogenic effect relevant to humans, up to the highest dose tested.

Pierre Broqua, Chief Scientific Officer and cofounder of Inventiva, said: “The FDA’s positive decision is consistent with the favorable and differentiating safety profile of our lead product candidate as already observed in pre-clinical and clinical trials to date confirming lanifibranor’s differentiation from other PPAR agonists. This decision is key as it removes a significant barrier to moving ahead with our planned Phase III pivotal trials in NASH.”

About lanifibranor

Lanifibranor, Inventiva’s lead product candidate, is an orally-available small molecule that acts to induce antifibrotic, anti-inflammatory and beneficial metabolic changes in the body by activating all three peroxisome proliferator-activated receptor (“PPAR”) isoforms, which are well-characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well-balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only pan-PPAR agonist in clinical development. Inventiva believes that lanifibranor’s moderate and balanced pan-PPAR binding profile contributes to the favorable safety and tolerability profile that has been observed in clinical trials and pre-clinical studies to date.

Inventiva is currently evaluating lanifibranor in a Phase IIb clinical trial for the treatment of non-alcoholic steatohepatitis (“NASH”), a common and progressive chronic liver disease, for which there is currently no approved therapy.

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick

Aude Hillion/ Yannick Tetzlaff
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management”s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva”s control.

There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

Inventiva to present new results of its YAP-TEAD oncology program at the AACR Special Conference on The Hippo Pathway

Inventiva to present new results of its YAP-TEAD oncology program at the AACR Special Conference on The Hippo Pathway

23 April 2019

Daix (France), April 23, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced that the abstract on the evaluation of its YAP-TEAD Protein-Protein Interaction inhibitors for treating Malignant Pleural Mesothelioma (MPM) submitted to the American Association for Cancer Research (AACR) has been accepted for a poster presentation at the upcoming AACR Special Conference on The Hippo Pathway: Signaling, Cancer, and Beyond (May 8-11, 2019, San Diego, California).

The study, which aimed at supporting a multi-pronged approach to treat MPM, will be presented by Anne Soudé, Senior Scientist in charge of the YAP-TEAD program at Inventiva. Amongst other results, the study showed that Inventiva’s YAP-TEAD inhibitors significantly reduced tumor growth in MPM xenograft and orthotopic models. In addition, synergistic effects were seen in a three dimensional spheroid modelsuggesting that the Company’s YAPTEAD inhibitors, when used in combination with existing chemotherapeutics, could attenuate multidrug resistance and re-sensitize chemo-resistant cancer cells.

Following these promising results, Inventiva has decided to expand its studies to other cancer indications as well as other combination strategies where standard of care agents are proven to be ineffective and where YAP is activated. Moreover, Inventiva is planning to study the capacity of its compounds to overcome immune evasion, another common challenge in treating cancer where the tumor is not recognized and eliminated by the immune system.

Pierre Broqua, Chief Scientific Officer and cofounder of Inventiva, commented: “These new results reinforce the rationale that our YAP-TEAD inhibitors could constitute a relevant approach to treat mesothelioma. We are particularly excited by the potential of our compounds to attenuate drug resistance in several cancers through an efficacious combination with standard of care. We are currently in the process of selecting a drug candidate for our oncology program and look forward to entering its pre-clinical development later this year.”

The abstract, which is entitled “Discovery of YAP-TEAD Protein-Protein Interaction inhibitors (PPI) for treating Malignant Pleural Mesothelioma (MPM)”, will be presented on Friday, May 10, 2019.

The details of the presentation are as follows:
Abstract title: “Discovery of YAP-TEAD Protein-Protein Interaction inhibitors (PPI) for treating Malignant Pleural Mesothelioma (MPM)”
Session: Poster Session B
Speaker: Anne Soudé, Senior Scientist in charge of target identification and validation, Inventiva
Date: Friday, May 10, 2019
Time: 12:30 pm – 2:30 pm (Pacific Daylight Time)
Location: Marriott Marquis San Diego Marina hotel, San Diego, California
Event: “AACR Special Conference on The Hippo Pathway: Signaling, Cancer, and Beyond”

About the YAP-TEAD program

The YAP-TEAD program aims to disrupt the interaction between yes-associated protein, or YAP, and transcription enhancer associated domain transcription factors, or TEAD, which occurs along the Hippo signaling pathway and which plays a key role in the oncogenic process. The Hippo signaling pathway is involved in the processes of cell differentiation and proliferation, tissue growth and organ size. Dysregulation along the Hippo signaling pathway has been associated with drug resistance, immune evasion, tumor growth and metastases. A great variety of cancers, particularly malignant mesothelioma, as well as lung cancer, triple negative breast cancer, hepatocellular carcinoma and hepatoblastoma, as well as fibrotic diseases, are displaying a dysfunction of the Hippo pathway.

In pre-clinical studies, Inventiva’s compounds prevented the formation of the YAP/TEAD transcriptional complex, reduced the expression of YAP/TEAD target genes and displayed anti-proliferative effects in cancer cell lines the proliferation of which is controlled by the Hippo signaling pathway, both as a monotherapy and in combination with approved cancer therapies. Furthermore, in xenograft models of Malignant Pleural Mesothelioma (MPM), the compounds produced significant tumor regression after oral administration.

Inventiva is currently in the process of selecting a clinical drug candidate for its oncology program, which it anticipates entering pre-clinical development later this year.

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick

Aude Hillion/ Yannick Tetzlaff
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management”s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva”s control.

There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

Inventiva to Participate at the H.C. Wainwright Global Life Sciences Conference

Inventiva to Participate at the
H.C. Wainwright Global Life Sciences Conference

3 April 2019

Daix (France), April 3, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced that Frédéric Cren, Chairman, CEO and cofounder of Inventiva, will present a corporate overview, followed by one-on-one meetings, at the upcoming H.C Wainwright Global Life Sciences Conference, being held on April 7-9, 2019, at the Grosvenor House in London.

The event details are as follows:

Date: Tuesday, April 9, 2019

Time of presentation: 9:50 am – 10:10 am (GMT)

Location of presentation: North Suite, Grosvenor House, London

The presentation document will also be available on Inventiva’s website in the “Investors” – “Investor Presentations” section.

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick

Aude Hillion/ Yannick Tetzlaff
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management”s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva”s control.

There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

Inventiva to Present Corporate Overview at the Cowen and Company 39th Annual Health Care Conference

Inventiva to Present Corporate Overview at the Cowen and Company 39th Annual Health Care Conference

6 March 2019

Daix (France), March 6, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced that Frédéric Cren, Chairman, CEO and cofounder of Inventiva, will present a corporate overview, followed by a breakout session, at the upcoming Cowen and Company 39th Annual Health Care Conference, being held on March 11-13, 2019 at the Marriott Hotel in Boston, Massachusetts.

The event details are as follows:

Date: Monday, March 11, 2019

Time of presentation: 3:30 pm – 4:00 pm (Eastern Time)

Time of breakout session: 4:10 pm – 4:40 pm (Eastern Time)

Location of presentation: Orleans Room, 4th Floor, Boston Marriott Copley Place, Boston, Massachusetts

Location of breakout session: Hyannis Room, 4th Floor, Boston Marriott Copley Place, Boston, Massachusetts

Webcast: http://wsw.com/webcast/cowen52/iva/

The presentation document and the link to the webcast will also be available on Inventiva’s website in the “Investors” – “Investor Presentations” section.

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick

Aude Hillion/ Yannick Tetzlaff
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management”s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva”s control.

There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

The FDA Grants Rare Pediatric Disease Designation to Odiparcil for the Treatment of MPS VI

The FDA Grants Rare Pediatric Disease Designation to Odiparcil for the Treatment of MPS VI

5 March 2019

Daix (France), March 05, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation (RPDD) to odiparcil, the Company’s product candidate in development for the treatment of mucopolysaccharidosis (MPS) VI, a type of rare, progressive genetic disorder characterized by a deficiency in the lysosomal enzymes responsible for the normal degradation of glycosaminoglycans (GAGs). The designation of rare pediatric disease status confirms odiparcil’s eligibility to receive a Priority Review Voucher upon FDA approval of a new drug application (NDA) to be filed for odiparcil for the treatment of MPS VI.

Pierre Broqua, Ph.D., Chief Scientific Officer and cofounder of Inventiva, declared: “This important designation from the FDA illustrates the severity of MPS VI in the pediatric population. We look forward to continued collaboration with the FDA in advancing odiparcil as a therapy in such a rare and life-threatening disease for which there is still a significant unmet medical need .

The FDA defines “rare pediatric diseases” as diseases with serious or life-threatening manifestations that primarily affect people who are less than 18 years old and that affect fewer than 200,000 people in the United States. Under the FDA’s RPDD program, a sponsor who receives approval of an NDA or a biologics license application (BLA) for a product for the prevention or treatment of a designated rare pediatric disease may be eligible for a voucher, which can be redeemed to obtain priority review for a future submission of an NDA or BLA. Redeemed vouchers can reduce FDA review time from twelve to six months. Priority Review Vouchers may be used by the sponsor, or sold or transferred to a third party, with prices ranging from $67.5 million to $350 million since the first one was issued in 2009. The last voucher was sold in October 2018 for $80 million.[1]

About odiparcil

Odiparcil is an orally-available small molecule that acts on the underlying cause of the symptoms of MPS. MPS is characterized by the accumulation of GAGs, which are important for the modulation of cell‑to‑cell signaling and the maintenance of tissue structure and function, in the lysosomes of cells. Due to genetic mutations, lysosomes in patients with MPS contain deficient versions of the enzymes necessary to break down GAGs. As a result, GAGs accumulate within the lysosomes, causing the latter to swell and interfere with the ordinary functioning of cells, thus leading to the symptoms associated with MPS. MPS is categorized by subtypes, depending on the enzyme that is deficient and the corresponding GAGs that accumulate. By modifying how GAGs are synthesized, odiparcil facilitates the production of soluble GAGs that can be excreted in the urine, rather than accumulating in cells. Specifically, odiparcil acts on chondroitin sulfate and dermatan sulfate, either or both of which accumulate in patients with MPS subtypes I, II, IVa, VI and VII.

Inventiva is currently evaluating odiparcil in a Phase IIa clinical study for the treatment of adult patients with MPS VI.

Odiparcil has been granted orphan drug status for the treatment of MPS VI by the FDA and the European Medicines Agency.

About the Phase IIa iMProveS clinical trial

The iMProveS (Improve MPS treatment) clinical trial is a 26-week Phase IIa clinical trial evaluating odiparcil for the treatment of adult patients with MPS VI. The primary endpoint of the trial is safety, as assessed by clinical and biological standard tests. Secondary endpoints include changes from baseline in leukocyte, skin and urinary GAG content, and improvements of activity and mobility, cardiovascular, lung and respiratory function, and vision and hearing impairments.

Inventiva expects to enrol 18 adult MPS VI patients currently receiving enzyme replacement therapy (ERT) in a double-blind placebo-controlled study and six patients not receiving ERT in an open label cohort at two sites in Europe. Results of the trial are expected in the second half of 2019.

[1] Source: Biocentury May 4, 2018 “Voucher Equilibrium”; Biocentury November, 1st 2018 “Lilly buys Siga’s priority review voucher gained via smallpox approval”.

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick

Aude Hillion/ Yannick Tetzlaff
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management”s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva”s control.

There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

Inventiva announces further progress achieved in the clinical development of lanifibranor for the treatment of NASH

Inventiva announces further progress achieved in the clinical development of lanifibranor for the treatment of NASH

21 February 2019

Daix (France) February 21st, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced the screening of the first patient in the United States for its Phase IIb NATIVE (NASH Trial to Validate IVA337 Efficacy) clinical trial evaluating lanifibranor, the Company’s lead product candidate, for the treatment of non-alcoholic steatohepatitis (NASH), a common and progressive chronic liver disease for which there is currently no approved therapy. Inventiva also announced that the NATIVE Data Safety Monitoring Board (DSMB) held its second meeting and recommended that the trial continue as planned.

The screening of the first patient in the United States follows the positive review by the U.S. Food and Drug Administration (FDA) of the NATIVE trial protocol and the inclusion of 14 sites in the United States in the trial, which brought the total number of sites involved to 91. Out of 225 patients expected to be enrolled in the trial, 155 patients have been randomized, and 71 patients have already completed the six-months treatment. The NATIVE trial continues to progress as planned and results are anticipated in the first half of 2020.

Pr Sven Francque, M.D., Ph.D. from the Antwerp University Hospital and Co-Principal Investigator, said: “The news of the first patient screened in the U.S. and the opening of 14 sites represents great progress. We expect to open 5 additional sites in Europe to further accelerate patient recruitment. Given the study design and lanifibranor’s mechanism of action, we believe that the results of the NATIVE trial, if positive, will support lanifibranor’s move into the pivotal Phase III trial.”

Pr Manal Abdelmalek, M.D., M.P.H. from Duke University, who agreed to act as Co-Principal Investigator with Pr Sven Francque, stated: “I am very pleased to be a part of this important trial and am excited by the profile of lanifibranor, a drug that is designed to act on many features of NASH by combining anti-fibrotic and anti-inflammatory activities with metabolic benefits, including improvement of insulin sensitivity.”

“The NATIVE trial is rolling out in the United States as planned and we are excited to add U.S. sites to the study, making NATIVE a truly international trial. We are thrilled to welcome Pr Abdelmalek, a renowned hepatologist, to the Steering Committee of the NATIVE trial and we look forward to finalizing recruitment over the coming months,” added Inventiva’s Chief Medical Officer, Marie-Paule Richard, M.D.

In addition, the NATIVE DSMB has reviewed the available safety data from the trial and recommended, for the second time, that the trial continue without modification to the protocol. The positive outcome of this second DSMB review is consistent with the results of long-term toxicological studies, as well as of Phase I and Phase II clinical trials, which have shown that lanifibranor is associated with a favorable safety profile.

About lanifibranor

Lanifibranor, Inventiva’s lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial metabolic changes in the body by activating all three peroxisome proliferator‑activated receptor (“PPAR”) isoforms, which are well‑characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well‑balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms, lanifibranor is the only pan‑PPAR agonist in clinical development. Inventiva believes that lanifibranor’s moderate and balanced pan‑PPAR binding profile contributes to the favorable safety and tolerability profile that has been observed in clinical trials and pre‑clinical studies to date.

About the NATIVE Phase IIb trial

The NATIVE (NAsh Trial to Validate IVA337 Efficacy) clinical trial is a 24-week treatment, randomized, double-blind, placebo-controlled Phase IIb clinical trial evaluating lanifibranor in the treatment of patients with non-alcoholic steatohepatitis (“NASH”). The goal of the trial is to assess the effect of lanifibranor on the improvement in liver inflammation and ballooning, which are two of the markers of the resolution of NASH. To be considered for inclusion, patients must have: a diagnosis of NASH confirmed by liver biopsy; a cumulative score of inflammation and ballooning (as measured using the steatosis, activity and fibrosis, or “SAF”, scoring system) of three or four out of four, indicating the presence of moderate to severe inflammation and ballooning; a steatosis score greater than or equal to one, indicating the presence of moderate to severe steatosis; and a fibrosis score less than four, indicating the absence of cirrhosis. The primary endpoint of the trial is a reduction in the combined inflammation and ballooning score of two points compared to baseline, without worsening fibrosis. Secondary endpoints include NASH resolution, improvements in each of the steatosis, inflammation, ballooning and fibrosis scores from baseline as measured using the SAF score, improvements in various other fibrosis measures, improvements in several metabolic markers, improvements in steatosis, inflammation and ballooning as measured using the “NAS” score, and safety.

The trial is expected to enrol 225 patients with NASH at more than 90 sites in Europe, the United States, Canada, Australia and Mauritius. Results of the trial are expected in the first half of 2020.

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick

Aude Hillion/ Yannick Tetzlaff
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management”s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva”s control.

There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

Inventiva Announces Results From Phase IIb Clinical Trial with Lanifibranor in Systemic Sclerosis

Inventiva Announces Results from Phase IIb Clinical Trial with Lanifibranor in Systemic Sclerosis

18 February 2019

Daix (France), February 18, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced the results from the FASST (For A Systemic Sclerosis Treatment) clinical trial evaluating lanifibranor for the treatment of patients with diffuse cutaneous systemic sclerosis (“dcSSc”), a rare, progressive autoimmune, rheumatic disease with frequent serious adverse events and high unmet medical need.

The FASST clinical trial, a one-year,  double-blind, randomized, placebo-controlled Phase IIb study, included 145 patients suffering from the early phase of dcSSc, who received lanifibranor in either two doses of 400mg per day or two doses of 600mg per day over 48 weeks in addition to their existing standard of care, which in most cases included immunosuppressive therapy.

The FASST clinical trial did not meet its primary endpoint of a mean absolute change from baseline to week 48, relative to placebo, in the modified Rodnan Skin Score (“mRSS”), which assesses skin thickness across 17 defined points on the body on a scale of zero, indicating normal skin, to three, indicating severe thickness. There was a decrease in the average mRSS observed in active and placebo arms with only four patients reporting to have increases in mRSS scores over the course of the trial.

800mg lanifibranor1200mg lanifibranorPlacebo
Number of patients494848
Mean baseline mRSS (SD[1])18.2 (3.8)17.8 (3.9)17.1 (-3.7)
Mean absolute change of mRSS from baseline to week 48 (SD3)-3.7 (4.2)-4.3 (5.0)-4.9 (4.6)

While the trial did not meet any of the secondary endpoints, lanifibranor showed a favorable trend in patients’ global assessment of disease activity with a mean absolute change in visual analog scale[2] (p=0.08) from baseline versus placebo indicating a perceived benefit by patients.

Within this fragile and poly-medicated population, lanifibranor was observed to be associated with a favorable safety profile, with no adverse interactions with immunosuppressive background therapies observed. The proportion of patients with at least one adverse event was similar across the three patient groups.

As reported in established literature, patients in the early phase of SSc population have an increased susceptibility to edema.[3] In the FASST clinical trial, fluid retention was observed related to lanifibranor but was only judged severe in one patient in each dose group, and a single serious adverse event of peripheral edema was observed at the highest lanifibranor dose. Furthermore, no cardiac or renal safety concerns were observed in the trial.

Yannick Allanore, co-principal investigator of the FASST clinical trial and professor of rheumatology at the Hôpital Cochin in Paris, commented: “The FASST clinical trial was well-conducted and represents the first study in dcSSc with a stratified background on immunosuppressive therapy. It appears that the presence of background therapy produced a strong placebo effect and limited the number of patients progressing in dcSSc.”

Professor Christopher Denton, co-principal investigator of the FASST clinical trial and professor at the University College of London, added: “We regret the study results but we are satisfied both by lanifibranor patients’ well-being, expressed in their global assessment, and lanifibranor’s favorable safety profile observed in the trial, including in combination with immunosuppressive drugs.”

Based on the FASST clinical trial results, Inventiva plans to discontinue lanifibranor’s clinical development for the treatment of dcSSc in order to fully focus on the development of lanifibranor for the treatment of NASH, of odiparcil for the treatment of mucopolysaccharidoses (MPS), and of YAP-TEAD in the field of oncology.

Frédéric Cren, Chairman and CEO of Inventiva, said: “We are disappointed by the results of the FASST clinical trial in dcSSc, a challenging disease as evidenced by the recent failure of three other late-stage trials. While we have decided to discontinue the lanifibranor program in SSc, we are very grateful for the dedication and commitment of patients, caregivers, investigators and our team to this program. We remain confident in lanifibranor’s unique mechanism of action and will therefore continue to move forward, as planned, with its clinical development in the treatment of NASH. Beyond lanifibranor, we have a promising and diversified development pipeline, backed by a strong discovery engine, notably with odiparcil for the treatment of mucopolysaccharidoses, and look forward to the upcoming clinical milestones.”

Results presentation

Inventiva’s management team will present the trial results in the context of the Company’s 2018 full-year results which will be published on Wednesday February 27, 2018 at 5:45 pm (Paris time).

On that occasion, the Company will host  a conference call in English at 6:15 pm (Paris time). The conference call will be simultaneously webcast and accessible on Inventiva’s website in the “Investors” – “Financial Results & Presentations” section. A replay of the conference call and webcast will also be available following the event.

More details on the conference call and webcast will be provided in the Company’s 2018 full-year results’ press release.

About the FASST Phase IIb trial

The FASST (For A Systemic Sclerosis Treatment) clinical trial was a one-year randomized, double-blind, placebo-controlled Phase IIb clinical trial evaluating lanifibranor in the treatment of patients with diffuse cutaneous systemic sclerosis (“dcSSc”), which affects approximately 35% of patients with systemic sclerosis (“SSc”). The primary endpoint of the trial was a mean absolute change from baseline to week 48 in the modified Rodnan Skin Score (“mRSS”), which assesses skin thickness across 17 defined points on the body on a scale of zero, indicating normal skin, to three, indicating severe thickness. The mRSS is a clinically validated and FDA‑accepted endpoint measuring the evolution of skin fibrosis, which is known to be correlated with internal organ fibrosis. In addition, secondary endpoints for the trial included changes in forced vital capacity (“FVC”), which is an FDA‑accepted endpoint measuring pulmonary function, overall progression of the disease (assessed as the absence of rescue therapy and of severe organ involvement, such as kidney failure), changes in gastrointestinal health, and safety.

About lanifibranor

Lanifibranor, Inventiva’s lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial metabolic changes in the body by activating all three peroxisome proliferator‑activated receptor (“PPAR”) isoforms, which are well‑characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well‑balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only pan‑PPAR agonist in clinical development. Inventiva believes that lanifibranor’s moderate and balanced pan‑PPAR binding profile contributes to the favorable safety and tolerability profile that has been observed in clinical trials and pre‑clinical studies to date.

Inventiva is currently evaluating lanifibranor in a Phase IIb clinical trial for the treatment of non-alcoholic steatohepatitis (“NASH”), a common and progressive chronic liver disease, for which there is currently no approved therapy.

About Systemic Sclerosis

SSc is a rare, progressive and debilitating chronic autoimmune rheumatic disease that is characterized by microvascular damage, dysregulation of the immune system and generalized fibrosis in multiple organs. As such, SSc affects the skin, lungs, heart, gastrointestinal tract and kidneys, with the impairments of the internal organs the most disabling and life-threatening manifestations of the disease.

It causes patients to suffer from major disability, significantly impaired quality of life and shorter life expectancy, primarily due to organ failure. SSc is potentially fatal, with the cause typically being cardio-respiratory failure. SSc patients have a greater mortality rate than patients with any other rheumatic disease. The prevalence of SSc is estimated to be 154 people per million in each of the United States and Europe and women are five times more likely than men to develop the disease.

As of today, there are no approved treatments for SSc.

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick

Aude Hillion/ Yannick Tetzlaff
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management”s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva”s control.

There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

New results on lanifibranor to be presented at the International Liver Congress™ 2019

New results on lanifibranor to be presented at the International Liver Congress™ 2019

4 February 2019

Daix (France), February 4, 2019 – Inventiva S.A. (“Inventiva”), a biopharmaceutical company developing innovative therapies in nonalcoholic steatohepatitis (“NASH”), systemic sclerosis and mucopolysaccharidosis (“MPS”), today announced that the abstract submitted by Pr Frank Tacke[1] MD, PhD, to the European Association for the Study of the Liver comparing in a mouse model the effects on the disease characteristics of NASH of the pan-PPAR agonist lanifibranor against the effects of certain single PPARα, PPARγ and PPARδ agonists has been accepted for an oral presentation at the International Liver Congress™ 2019 (April 10-14, 2019, Vienna, Austria).

 

The study, led by Pr Frank Tacke, found that administration of lanifibranor was associated with a combination of beneficial effects on many NASH characteristics, as well as with more potent effects on inflammation and disease progression than the tested single PPAR agonists. More specifically, administration of lanifibranor was associated with increased circulating adiponectin, reduced triglycerides and attenuated hepatocyte ballooning. Additionally, administration of lanifibranor and, to a lesser extent the tested single PPARa agonist, were associated with improvements in steatosis and lobular inflammation. Administration of lanifibranor was also associated with a more pronounced improvement of fibrosis than all of the other tested single PPAR agonists, suggesting that lanifibranor may combine the beneficial effects of single PPAR agonists and may counter inflammation and disease progression more potently. As a result, the study suggests that pan-PPAR agonists, such as lanifibranor, have the potential for more therapeutic effectiveness than single-PPAR agonists in the treatment of NASH.

 

The abstract, which is entitled “Differential therapeutic effects of pan- and single PPAR agonists on steatosis, inflammation, macrophage composition and fibrosis in a murine model of non-alcoholic steatohepatitis,” will be presented on April 11th.  The details of the presentation are as follows:

 

Event:                                              International Liver Congress™ 2019, Vienna, Austria

Date:                                                Thursday, April 11th, 2019

Time of the presentation:           5.30 pm to 5.45 pm (Central European Time)

Session:                                           NAFLD Pathophysiology – Target identification

Speakers:                                        Sander Lefere[2]

 

Background on PPARs

 

Peroxisome proliferator-activated receptors (“PPARs”) are nuclear receptors essential for the regulation of glucose and lipid metabolism in the liver and adipose tissue. They are also expressed in immune cells, notably macrophages, where they act as modulators of inflammation and fibrogenesis. Various single or dual PPAR agonists have been clinically evaluated in NASH, yielding variable effects on aspects of NASH pathogenesis.

[1] Dept. of Gastroenterology, Metabolic Diseases and Intensive Care Medicine, University Hospital Aachen, Germany / Department of Hepatology/Gastroenterology, Charité University Medical Center, Berlin, Germany

[2]PhD student, Ghent University

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick
Julien Trosdorf / Yannick Tetzlaff

Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management”s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva”s control.

There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

Inventiva invited to present at the 37th Annual J.P. Morgan Healthcare Conference

Inventiva invited to present at the 37th Annual J.P. Morgan Healthcare Conference

December 10, 2018

Daix (France), December 10, 2018 – Inventiva S.A. (“Inventiva” or the “Company”), a biopharmaceutical company
developing innovative therapies in nonalcoholic steatohepatitis (NASH), systemic sclerosis (SSc) and
mucopolysaccharidosis (MPS), today announced that Frédéric Cren, Chairman, CEO and cofounder of Inventiva,
has been invited to present a corporate overview, followed by a Q&A session, at the upcoming 37th Annual J.P.
Morgan Annual Healthcare Conference, being held on January 7-10, 2019 at the Westin St. Francis Hotel in San
Francisco, California.

The event details are as follows:

Date: Wednesday, January 9, 2019
Time of the presentation: 12:00 pm to 12:25 pm (Pacific Standard Time)
Time of the Q&A session: 1:30 pm to 1:55 pm (Pacific Standard Time)
Location: The Westin St. Francis Hotel, San Francisco, California

The presentation document and the link to the webcast will also be available on Inventiva’s website in the
“Investor” – “Documentation” – “Investor presentations” section.

 

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick
Julien Trosdorf / Yannick Tetzlaff

Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management”s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva”s control.

There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

Inventiva Announces Poster Presentation on Its YAP/TEAD Inhibitor Program at the EORTC-NCI-AACR Symposium in Dublin

Inventiva Announces Poster Presentation on Its YAP/TEAD Inhibitor Program at the EORTC-NCI-AACR Symposium in
Dublin

Novembre 7, 2018

Recent results reveal potential of oral small molecules in pre-clinical development by Inventiva targeting the YAP/TEAD pathway as a potential therapy in the treatment of mesothelioma and non-small cell lung cancer

Daix (France), November 7, 2018 – Inventiva S.A. (“Inventiva” or the “Company”), a biopharmaceutical company developing innovative therapies in non-alcoholic steatohepatitis (NASH), systemic sclerosis (SSc), and mucopolysaccharidosis (MPS), today announced that it will be presenting a poster on its YAP/TEAD pre-clinical program at the upcoming EORTC-NCI-AACR Molecular Targets and Therapeutics Symposium being held on November 13-16, 2018 in Dublin, Ireland.

The poster to be presented, entitled “Discovery of promising anti-cancer drug combination using YAP-TEAD inhibitors with standard of care treatment in mesothelioma and NSCLC cells”, illustrates some of the recent data observed by Inventiva in pre-clinical studies, which suggest that the YAP/TEAD inhibitor molecules being investigated by the Company may have potential as a therapy in the treatment of mesothelioma, Non-Small Cell Lung Cancer (NSCLC) and other cancers.

Inventiva’s YAP/TEAD approach aims at disrupting the formation of the transcriptional complex formed by YAP and TEAD, which are believed to be key players in the oncogenic process as well as in fibrogenesis.

Inventiva has observed that its lead YAP/TEAD inhibitor molecules have prevented the formation of the YAP/TEAD transcriptional complex in vitro and are associated with a reduction of YAP/TEAD target genes expression and anti-proliferative effects in cancer cell lines where proliferation is under the control of the Hippo pathway. The Company has also observed in xenograft and patient-derived xenograft (PDX) mice models that its YAP/TEAD inhibitor molecules exhibited activity both as a stand-alone treatment or in combination with standard of care.

Based on these promising results, the Company plans to finalize the toxicological studies necessary to advance its YAP/TEAD program into Phase I/II clinical development in 2019.

“We have made significant progress in our understanding of the Hippo pathway, which offers exciting potential for the treatment of rare and prevalent cancers,” stated Pierre Broqua, Chief Scientific Officer and cofounder of Inventiva. “We have observed that our patented small molecules exhibited activity both as a stand-alone treatment and in combination with standard of care in pre-clinical models. In addition, molecules that inhibit the YAP/TEAD interaction have already shown a potential to overcome drug resistance and tumor escape mechanisms, which makes this pathway particularly interesting. Our program is advancing well and we are looking forward to see it progressing into Investigational New Drug (IND) enabling studies.”

The event details for the presentations are as follows:

Poster Title: “Discovery of promising anti-cancer drug combination using YAP-TEAD inhibitors with standard of care treatment in mesothelioma and NSCLC cells”
Session Title: Drug Resistance and Modifiers
Date: Tuesday, November 13th
Time: 10am to 2pm
Location: The Convention Centre, Spencer Dock, North Wall Quay, Dublin, Ireland

About the EORTC-NCI-AACR Symposium

Hosted by the European Organization for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI) and the American Association for Cancer Research (AACR), the 30th edition of the EORTC-NCI-AACR Symposium in 2018 brings together academics, scientists and industry representatives to discuss the latest developments in drug development, target selection and the impact of new discoveries in molecular biology.

 

Contacts

Inventiva
Frédéric Cren

Chief Executive Officer
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick
Julien Trosdorf / Yannick Tetzlaff

Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

LifeSci Advisors
Monique Kosse

Investor relations
monique@lifesciadvisors.com

About Inventiva
Inventiva is a biopharmaceutical company specialized in the development of drugs interacting with nuclear receptors, transcription factors and epigenetic modulators. Inventiva’s research engine opens up novel breakthrough therapies against fibrotic diseases, cancers and orphan diseases with substantial unmet medical needs.

Lanifibranor, its lead product, is an anti-fibrotic treatment acting on the three alpha, gamma and delta PPARs (peroxisome proliferator-activated receptors), which play key roles in controlling the fibrotic process. Its anti-fibrotic action targets two initial indications with substantial unmet medical need: NASH, a severe and increasingly prevalent liver disease already affecting over 30 million people in the United States, and systemic sclerosis, a disease with a very high mortality rate and for which there is no approved treatment to date.

Inventiva is also developing a second clinical program with odiparcil (IVA 336) for the treatment of patients with mucopolysaccaridosis type VI (or Maroteaux-Lamy syndrome), a rare and severe gene disease affecting children. Odiparcil has also the potential to address other MPS types, characterized by the accumulation of chondroitin or dermatan sulfate (MPS I or Hurler/Sheie syndrome, MPS II or Hunter syndrome, MPS IVa or Morquio syndrome and MPS VII or Sly syndrome). Inventiva is also developing a portfolio of early research projects in the field of oncology.

Inventiva benefits from partnerships with world-leading research entities such as the Institut Curie in the field of oncology. Two strategic partnerships have also been established with world-class major pharmaceutical companies AbbVie and Boehringer Ingelheim in the fields of autoimmune diseases (specifically in psoriasis) and fibrosis respectively. These partnerships provide milestone payments to Inventiva upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on the products resulting from the partnerships.

Inventiva employs over 100 employees and owns R&D facilities near Dijon, acquired from the international pharmaceutical group Abbott. The Company owns, a proprietary chemical library of over 240,000 molecules as well as integrated biology, chemistry, ADME and pharmacology platforms.

Important Notice
This press release contains forward-looking statements, forecasts and estimates with respect to the clinical development
plans, business and regulatory strategy, and anticipated future performance of Inventiva and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management”s beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva”s control.

There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

Please refer to the “Document de référence” filed with the Autorité des Marchés Financiers on April 13, 2018 under n° R.18-013 for additional information in relation to such factors, risks and uncertainties.

Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.

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