News & Events

Inventiva’s Odiparcil Awarded Orphan Drug Designation for the Treatment of MPS VI by the European Medicines Agency

Inventiva’s Odiparcil Awarded Orphan Drug Designation for the Treatment of MPS VI by the European Medicines Agency

August 29, 2017

> FDA Orphan Drug Designation received earlier this month

> EMA and FDA Orphan designations validate odiparcil potential to improve treatment options for MPS VI patients

> iMProveS phase IIa study in MPS VI patients on track to begin recruitment by year-end 2017

Daix (France), August 29, 2017 at 07:30am CEST – Inventiva, a biopharmaceutical company developing innovative therapies, particularly in fibrosis, today announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to odiparcil (formerly IVA336) for the treatment of MPS VI.

This decision could accelerate the availability of a much needed new treatment for MPS VI patients,;” said Christine Lavery, President of the UK MPS Society added Professor Chris Hendriksz, of FYMCA Medical Ltd. and University of Pretoria, South Africa.

We recently received U.S. orphan drug status and with this new EU designation we continue delivering on our regulatory strategy for odiparcil. Clearly the recent preclinical data we generated showing that odiparcil is active in organs where marketed enzyme replacement therapies have limited or no efficacy, has been instrumental in convincing regulators to grant these ODD designations. These designations confirm that regulatory agencies share our view that odiparcil could improve MPS VI current treatment options,” concluded Pierre Broqua, Chief Scientific Officer and Co-Founder of Inventiva.

MPS VI (Maroteaux-Lamy syndrome), is a rare pediatric genetic degenerative disease with a prevalence estimated to be 1 in 225,000 live births. There is no cure for MPS VI and current treatment options, such as enzyme replacement therapy (ERT) or hematopoietic stem cell transplant (HSCT), leave the patients with high unmet medical needs.

Odiparcil, an orally available therapy, is being developed as a potential therapy for MPS I, II, and VI patients. Inventiva is currently launching the Phase IIa iMProveS (improve MPS treatment) study, which is expected to enroll its first patient before year end. The iMProveS clinical study is a 26-week study designed to demonstrate the safety, tolerability, and efficacy of odiparcil in 24 adult MPS VI patients and will be conducted at two European clinical sites. If the results of this study are positive, the company plans to pursue a pivotal Phase III study of odiparcil in patients with MPS VI.

About Orphan Drug Designation

The EMA grants Orphan Drug Designation to support the development of medicines for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating and that affect no more than 5 in 10,000 individuals in the European Union. Orphan drug designation allows for companies to receive development incentives, such as protocol assistance, reduced fees for regulatory activities, and up to ten years of market exclusivity in the EU upon marketing approval for the designated indication.

About MPS VI

MPS VI (Maroteaux-Lamy syndrome), is a rare pediatric genetic degenerative diseases characterized by the abnormal functioning of the enzyme N-acetylgalactosamine 4-sulphatase (arylsulphatase B; ASB) leading to the accumulation of dermatan sulfate and chondroitin sulfate in the cells, tissues and organs. Patients have coarse faces, short stature, corneal clouding, hearing loss, dysostosis multiplex, hepatosplenomegaly, cardiac valve disease and reduced pulmonary function without intellectual deficit. As with other MPS, the time of onset, rate of progression and extent of the disease may vary between the affected individuals. The life expectancy of MPS VI patients, if untreated, is approximately 20 years in patients with severe forms of the disease, or longer in patients with less severe forms.

The prevalence of MPS VI is estimated to be 1 in 225,000 live births and varies between countries. There is no cure for MPS VI and current treatment options such as enzyme replacement therapy (ERT) or hematopoietic stem cell transplant (HSCT) leave the patients with high unmet medical needs.

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.

Odiparcil Awarded Orphan Drug Designation for the Treatment of MPS VI by the FDA

Odiparcil Awarded Orphan Drug Designation for the Treatment of MPS VI by the FDA

August 10, 2017

> Odiparcil therapeutic potential and significant benefit over existing therapeutic options confirmed

> With a high medical need still existing, odiparcil could significantly improve the treatment options for MPS VI patients

> First patient enrollment in a Phase IIa study expected by year-end 2017

Daix (France), August 10, 2017 at 5:45 pm CEST – Inventiva, a biopharmaceutical company developing innovative therapies, particularly in fibrosis, today announced that the FDA has granted Orphan Drug Designation to odiparcil (formerly IVA336) for the treatment of MPS VI.

MPS VI (Maroteaux-Lamy syndrome), is a rare pediatric genetic degenerative disease. The prevalence of MPS VI is estimated to be 1 in 225,000 live births. There is no cure for MPS VI and current treatment options such as enzyme replacement therapy (ERT) or hematopoietic stem cell transplant (HSCT) leave the patients with high unmet medical needs. “MPS are devastating diseases and odiparcil could become an important advance in providing optimal therapy for many patients struggling with lysosomal disorders,” said Professor Paul Harmatz (Children’s Hospital & Research Center of Oakland, Oakland, California).

“The FDA’s decision to award Orphan Drug Designation to odiparcil in the treatment of MPS VI patients is another important milestone as it confirms that odiparcil may bring a significant therapeutic benefit over existing approved medications”, added Pierre Broqua, Chief Scientific Officer and Co-Founder of Inventiva. “MPS VI remains a severe disease despite the availability of an enzyme replacement therapy, and this decision is a strong and encouraging signal from the FDA to move forward with our clinical program.”

Odiparcil, an orally available therapy, is being developed as a potential therapy for MPS I, II, and VI patients. Inventiva is currently launching the Phase IIa iMProveS (improve MPS treatment) study which is expected to enroll its first patient before year end. The iMProveS clinical study is a 26-week study designed to demonstrate the safety, tolerability, and efficacy of odiparcil in 24 adult MPS VI patients and will be conducted at two European clinical sites. If the results of this study are positive, the company plans to initiate a pivotal Phase III study in the US and in the EU with odiparcil in MPS VI patients.

About Orphan Drug Designation:

Orphan Drug Designation is granted by the FDA to novel therapeutics for diseases or conditions affecting fewer than 200,000 patients in the U.S. or greater than 200,000 patients if there is no reasonable expectation that the production cost of the drug will be covered by its sales. The designation allows the drug developer to be eligible for a seven-year period of

U.S. marketing exclusivity upon approval of the drug, as well as, in some cases, tax credits for clinical research costs, the ability to apply for annual grant funding, clinical trial design assistance, and the waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

About MPS VI:

MPS VI (Maroteaux-Lamy syndrome), is a rare pediatric genetic degenerative diseases characterized by the abnormal functioning of the enzyme N-acetylgalactosamine 4-sulphatase (arylsulphatase B; ASB) leading to the accumulation of dermatan sulfate and chondroitin sulfate in the cells, tissues and organs. Patients have coarse faces, short stature, corneal clouding, hearing loss, dysostosis multiplex, hepatosplenomegaly, cardiac valve disease and reduced pulmonary function without intellectual deficit. As with other MPS, the time of onset, rate of progression and extent of the disease may vary between the affected individuals. The life expectancy of MPS VI patients, if untreated, is approximately 20 years for patients with severe forms of the disease and more for patients with less severe forms.

The prevalence of MPS VI is estimated to be 1 in 225,000 live births. It varies between countries. There is no cure for MPS VI and current treatment options such as enzyme replacement therapy (ERT) or hematopoietic stem cell transplant (HSCT) leave the patients with high unmet medical needs.

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 to Present New Data on IVA337 at the 15th International Workshop on Scleroderma Research in Pittsburgh, USA

Inventiva to Present New Data on IVA337 at the 15th International Workshop on Scleroderma Research in Pittsburgh, USA

July 27, 2017

> IVA337 Abstract Selected Among Best Papers

> IVA337 has demonstrated preservation of pulmonary activity confirming its potential as a treatment for systemic sclerosis (SSc) patients by acting on several components of fibrosis

Daix (France), July 27, 2017 at 5:45pm CEST – Inventiva, a biopharmaceutical company developing innovative therapies, particularly to treat fibrosis, today announced an abstract entitled “PAN-PPAR Agonist IVA337 is Effective in the Prevention of Experimental Lung Fibrosis and Pulmonary Hypertension” has been selected among the best papers in the upcoming 15th International Workshop on Scleroderma Research being held August 5-9, 2017 at the University of Pittsburgh in Pittsburgh, PA. The 4-day biennial research meeting is centered on translational medicine related to systemic sclerosis (SSc).

“The paper highlights new data, which confirm the wide anti-fibrotic activity of IVA337, especially in the organs of patients affected by SSc,” said Professor Yannick Allanore, Principal Investigator and President of the European Scleroderma Trials and Research group. “The preservation of pulmonary activity is impressive and could indicate that IVA337 could meet a high unmet medical need in SSc patients.”

“We are very pleased to have been selected among the best papers being presented during this international systemic sclerosis congress,” said Pierre Broqua, Ph.D., Chief Scientific Officer and Co-Founder of Inventiva. “The congress draws interest from leaders in translational medicine and we are proud to see the high level of interest in the activity of IVA337 among this elite group.”

The new data generated show that IVA337 induces a marked protection from the development of lung fibrosis with restoration of respiratory capacity and inhibits pulmonary arteries remodeling with positive impact on pulmonary artery pressure. This large spectrum of activity demonstrates in addition to the previously positive effects demonstrated on skin fibrosis, the therapeutic potential of IVA337 on cardiorespiratory involvements in SSc patients.

For more information on the 15th International Workshop on Scleroderma Research, refer to https://sscworkshop.wordpress.com/about/

Systemic sclerosis is a rare and complex fibrotic disease. Due to the progressive failure of different organs, systemic sclerosis is a severe disease with a high mortality rate. Once patients are diagnosed with systemic sclerosis, generally between the ages of 40 and 50, the median survival period is of 11 years. Close to 170,000 people suffer from systemic sclerosis, with women outnumbering men by a ratio of more than five to one1.

Deeper study of this skin fibrosis has led to its classification into two sub-categories, respectively called limited cutaneous systemic sclerosis and diffuse cutaneous systemic sclerosis. The latter is more serious and is targeted in the Inventiva’s FASST Phase 2b trial which is enrolling up to a total of 132 patients at 50+ sites across Europe.

To date, only symptomatic drugs with limited therapeutic effects are available in order to attenuate the consequences of fibrosis progression. However, they do not prevent, delay or reverse the disease’s devastating process. IVA337 could offer a curative treatment for SSc patients by acting on several components of fibrosis and on several organs.

About IVA337 and FASST Phase 2b study

IVA337 is a new chemical entity that activates the three PPAR (peroxisome proliferator-activated receptor) isoforms. The product has demonstrated good tolerability, safety and efficacy in Phase I and Phase IIa studies, in approximately 100 healthy volunteers and 60 type 2 diabetic patients. IVA337 has received orphan status designation from EMA and FDA in SSc and a Phase IIb FASST trial validated by EMA is ongoing in this indication.

FASST is a one-year randomized double-blind study designed to enroll up to a total of 132 patients at 50+ sites across Europe. Patients are being administered one of the two doses of IVA337 or placebo. The study protocol, approved by the European Medicines Agency (EMA), has been designed to demonstrate the beneficial effect of IVA337 on progression of SSc. The primary endpoint is a measure of the change in the modified Rodnan skin score, a measure of disease progression accepted by both FDA and the EMA. Inclusion criteria are based on a MRSS (Modified Rodnan Skin Score) between 10 and 25, and diffuse systemic sclerosis diagnosed from less than 3 years. Patients are permitted to continue with their ongoing treatments, including immunosuppressive therapies.

Journal of Rheumatology, 2013

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 New Compelling Data on Odiparcil/IVA336 to be Presented at MPS Society National Conference

Inventiva Announces New Compelling Data on Odiparcil/IVA336 to be Presented at MPS Society National Conference

June 29, 2017

> Confirmation of potential to be the first orally available substrate reduction therapy for MPS VI patients

> Phase IIa iMProveS clinical study scheduled to begin before year end 2017

Daix (France), June 29, 2017 – 6:00pm CEST – Inventiva, a biopharmaceutical company developing innovative therapies, particularly to treat fibrosis, today announced that Professor Chris Hendriksz, of FYMCA Medical Ltd. and University of Pretoria, South Africa, will be presenting new preclinical data on Odiparcil (formerly IVA336) in a closed session at the MPS Society National Conference, which will be held July 7-9, 2017 in Coventry, UK.

The data, generated over a 6-month treatment with two doses of Odiparcil in a genetic mouse model for MPS VI, demonstrate that Odiparcil restored a normal corneal structure in the eye, which could lead to a complete rescue of the disease phenotype in the eye. Odiparcil also reduced GAG accumulation in the liver, kidney, spleen, heart, eye, and skin of diseased animals and produced a dose-dependent reduction of cartilage thickness in the trachea and femoral growth plate. Finally mobility was improved by Odiparcil in the diseased animals.

These results demonstrate that Odiparcil has the potential to be the first orally available substrate reduction therapy for MPS VI patients. “These breakthrough pre-clinical results support the potential of Odiparcil as a new and very promising approach to treating MPS patients,” said Professor Hendriksz. “MPS are devastating diseases, and there remains a significant unmet medical need despite the availability of enzyme replacement therapies, which unfortunately are not able to resolve the symptoms occurring in certain regions especially in the ophthalmological system, joints, cartilages, cardiac valves etc. Odiparcil could prove beneficial to MPS patients as a substrate reduction therapy as a stand-alone treatment or in adjunction to current treatments.”

We are very excited by the data, as well as the positive feedback received from patients’ associations and MPS key opinion leaders. We are looking forward to the upcoming iMProveS trial, which could confirm the therapeutic benefit of Odiparcil, leading potentially to ERT replacement,” added Pierre Broqua, Ph.D., Chief Scientific Officer and Co-Founder of Inventiva.

In addition to the Odiparcil data, Professor Hendriksz will also present the design of the planned Phase IIa iMProveS (improve MPS treatment) clinical study, which is expected to enroll its first patient before year end. The iMProveS clinical study will be a 26-week study designed to demonstrate the safety, tolerability, and efficacy of Odiparcil in 24 adult MPS VI patients and will be conducted at two European clinical sites. Eighteen patients receiving enzyme replacement treatment (ERT) will be randomized into 3 arms: two active dose levels of Odiparcil (250 mg and 500 mg, bid) or placebo. The study will also include an additional arm of six patients untreated by ERT who will receive 500 mg bid of Odiparcil. This study, if positive, will allow for enrollment of MPS VI patients into the pivotal Phase III trial.

For more information on the MPS Society National Conference, refer to http://www.mpssociety.org.uk/2017/01/11/programme-uk-mps-conference-announced/

About MPS VI:

MPS VI (Maroteaux-Lamy syndrome), is a rare pediatric genetic degenerative diseases characterized by the abnormal functioning of the enzyme N-acetylgalactosamine 4-sulphatase (arylsulphatase B; ASB) leading to the accumulation of dermatan sulfate and chondroitin sulfate in the cells, tissues and organs. Patients have coarse faces, short stature, corneal clouding, hearing loss, dysostosis multiplex, hepatosplenomegaly, cardiac valve disease and reduced pulmonary function without intellectual deficit. As with other MPS, the time of onset, rate of progression and extent of the disease may vary between the affected individuals. The life expectancy of MPS VI patients, if untreated, is approximately 20 years for patients with severe forms of the disease and more for patients with less severe forms.

The prevalence of MPS VI is estimated to be 1 in 225,000 live births. It varies between countries. There is no cure for MPS VI and current treatment options such as enzyme replacement therapy (ERT) or hematopoietic stem cell transplant (HSCT) leave the patients with high unmet medical needs.

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 Peer Review Publication of IVA337 Data in Pre-Clinical NASH Models

Inventiva Announces Peer Review Publication of IVA337 Data in Pre-Clinical NASH Models

June 20, 2017

Data support therapeutic potential of IVA337 for the treatment of patients with NASH

Daix (France), June 20, 2017 – 6:00pm CEST – Inventiva, a biopharmaceutical company developing innovative therapies, particularly to treat fibrosis, today announced the peer review publication of data on the effects of its lead drug candidate IVA337, a pan-PPAR agonist currently in phase IIb clinical development in Non-Alcoholic Steatohepatitis (NASH), in various preclinical models of NASH. The paper Proliferator-Activated Receptor Agonist IVA337 Protects the Liver From Metabolic Disorders and Fibrosis is published in the June 19th, 2017 edition of Hepatology Communications;. Hepatology Communications ;is a peer- reviewed, online-only open access journal for fast dissemination of high quality basic, translational, and clinical research in hepatology supported by Wiley’s network of prestigious journals and societies.

The authors of the paper include several leading experts on NASH, including Professor Isabelle Leclerc from the University of Leuven (Belgium), Professor Derek Mann from the University of Newcastle (United Kingdom), Professor Sven Francque from the University Hospital of Antwerp (Belgium), as well as company scientists.

“We are pleased to announce this peer review publication of our IVA337 data. These studies demonstrate that the molecule improves metabolic parameters and NASH histopathologic features, such as steatosis, ballooning, inflammation, and fibrosis, in several relevant animal models,” said Pierre Broqua, Ph.D., Chief Scientific Officer and Co-Founder of Inventiva. “Based on these results, together with a good safety profile differing from previously developed PPAR agonists, we believe that IVA337 is a promising candidate for NASH treatment. We are currently enrolling patients in a Phase IIb trial in NASH.”

Summary of Key Findings from Preclinical NASH Studies:

The effects of IVA337 on several preclinical models reproducing the main metabolic and hepatic features associated with NASH were investigated. These models comprised a diet-induced obesity model (high-fat/high-sucrose diet); a methionine- and choline-deficient diet (MCD model); the foz/foz model; the CCl4-induced liver fibrosis model (prophylactic and therapeutic) and human primary hepatic stellate cells.
In the two latter models, IVA337 displayed an antifibrotic efficacy superior to selective PPARα PPARδ or PPARy agonists.

HF/HS model:

This diet-induced obesity model was used to evaluate the effect of IVA337 on insulin resistance and other parameters linked to metabolic syndrome. IVA337 dose dependently reduced body weight gain, normalized insulinemia and non-fasting glucose and reduced circulating leptin levels.

MCD model:

In mice fed with a methionine- and choline-deficient diet, IVA337 completely prevented steatosis and to a large extent reduced necroinflammatory changes.

HFD foz/ foz model:

The effect of IVA337 was investigated in the Alsm1 mutant foz/foz mice in which steatohepatitis occurs as a complication of severe obesity and insulin resistance. This model closely reproduces the natural history of NASH in humans. IVA337 largely attenuated steatosis and ballooning and reduced macrophage recruitment and fibrotic gene expression.

CCL4– liver fibrosis:

IVA337 demonstrated both preventive and curative effects on fibrosis induced by CCl4. IVA337 inhibited the expression of profibrotic and inflammasome genes while increasing the expression of ß- oxidation-related and fatty acid desaturation-related genes in both the methionine and choline-deficient diet and the foz/foz model.In vitro experiments were conducted to investigate the effect of IVA337 on human hepatic stellate cells (HSCs) which are the key cells driving liver fibrogenesis in NASH. IVA337 was shown to inhibit proliferation and activation of these cells.

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 to Present at the Jefferies 2017 Global Healthcare Conference

Inventiva to Present at the Jefferies 2017 Global Healthcare Conference

June 06, 2017

Daix (France), 6 June 2017 – 06:00pm CEST – Inventiva (Euronext Paris – FR0013233012 – IVA), a biopharmaceutical company developing innovative therapies, particularly to treat fibrosis, announced today that Frederic Cren, Chief Executive Officer, will present a corporate overview at the Jefferies 2017 Global Healthcare Conference, being held June 6-9 at the Grand Hyatt Hotel in New York City.

Presentation Details – Jefferies Global Healthcare Conference

Date: June 9
Time: 10:30am Eastern Time
Location: ballroom 4

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.

Dr Nanna Lüneborg, Principal of Novo Ventures, joins Inventiva’s Board

Dr Nanna Lüneborg, Principal of Novo Ventures, joins Inventiva’s Board

May 30, 2017

Daix (France), 30 May 2017 – 07:30pm CEST – Inventiva (Euronext Paris – FR0013233012 – IVA), a biopharmaceutical company developing innovative therapies, particularly to treat fibrosis, announced today the appointment Dr Nanna Lüneborg to the board of Inventiva, succeeding Mr Philippe Goupit. With this appointment, Inventiva’s Board of Directors comprises eight directors (three women and five men), including four independent directors.

Nanna Lüneborg is a Principal of Novo Ventures, a leading global life science investor, which participated in the IPO of Inventiva in February 2017. Novo Ventures is part of Novo A/S, the holding and investment company of the Novo Nordisk foundation.

Nanna Lüneborg has a background in medical research and life science venture capital. She completed her undergraduate studies at University of Oxford, PhD in Neuroscience from University College London, and MBA from the University of Cambridge. Prior to joining Novo A/S, she was part of the life science investment team at Apposite Capital, a London-based venture capital firm specialising in healthcare. In 2012, she joined Novo A/S, where she has been part of both the seed and venture investment teams. She has previous board experience from a range of biotech companies spanning start-up to late stage development, most recently from the board of ObsEva, which completed an IPO on NASDAQ earlier this year. She currently serves on the boards of Orphazyme and Epsilon-3 Bio, in addition to Inventiva.

On behalf of the Board of Directors and the Company as a whole, we warmly thank Philippe for his contribution to Inventiva’s development and wish him every success in his future projects;,” commented Frédéric Cren, Chairman and CEO of Inventiva. To succeed him, we are very pleased to welcome Nanna to our Board of Directors. Nanna’s experience will be valuable at this key stage in our development with the results of three clinical trials expected in 2018. We look forward to the advice and contribution she will bring.”;

“I am very pleased to be joining Inventiva’s Board of Directors. Inventiva has a promising portfolio of advanced products in fields that are stirring up significant interest in the pharmaceuticals industry. Being able to demonstrate positive results in NASH1, systemic sclerosis and MPS VI would constitute a major step forward for millions of patients who are still not receiving effective treatment,” added Dr Lüneborg. “This is an exciting time for the Company. Following the successful IPO, which gives it the financial means to realise its ambitions, I look forward to working in close collaboration with Inventiva’s Board of Directors and management team as the company moves ahead in the next key stages of its development.

About Novo Ventures:

Novo Ventures is part of Novo A/S, a private limited liability company, wholly owned by the Novo Nordisk Foundation. The company is the holding company in the Novo Group and is responsible for managing the assets of the Foundation. Besides being the major shareholder in the Novo Group companies, including Novo Nordisk A/S and Novozymes A/S, Novo A/S provides seed and venture capital to development-stage companies, takes significant ownership positions in well-established companies within the life sciences and manages a broad portfolio of financial assets. It has offices in Copenhagen, San Francisco, Boston and London with a team of scientific and commercial experts actively supporting a portfolio of projects and companies. For further information visit www.novo.dk.

1 Non-Alcoholic Steatotic Hepatitis

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 Positive Results of 12 Month Primate Toxicity Study with IVA337

Inventiva Announces Positive Results of 12 Month Primate Toxicity Study with IVA337

May 15, 2017

> No Adverse Clinical Signs Observed at Any Dose-Levels During the Treatment Period

Daix (France), May 15, 2017 – 6:00pm CEST –Inventiva, a biopharmaceutical company developing innovative therapies, particularly to treat fibrosis, announced today the results of a 12 month non-human primate toxicology study with its lead drug candidate IVA337, a pan PPAR agonist in phase IIb clinical development in non-alcoholic steato-hepatitis (NASH) and systemic sclerosis (SSc). No adverse clinical signs were observed during the treatment period at any dose-level and none of the typical adverse effects related to the thiazolidinones were observed.

This toxicology study was conducted to meet the regulatory requirements of health authorities including the FDA and EMA. Inventiva is also advancing with two carcinogenity studies of 24 month duration in rodents, and after 18 months of treatment both studies are progressing as planned. Once these are completed, Inventiva will have by mid-2018 the necessary toxicology package required to move into Phase III testing and for regulatory filing.

“These results will be important for the end of phase IIb discussions with regulatory authorities. Inventiva continues to deliver on its strategy to have IVA337 ready to enter into pivotal trials in NASH and SSc,” said Dr. Pierre Broqua, Chief Scientific Officer and Cofounder of Inventiva. “We are impressed by the benign profile of IVA337, which does not show the side effects typically observed with thiazolidinediones or fibrates” added Dr. Jeri El-Hage, Toxicologist and Regulatory Consultant, expert in the PPAR field at Aclairo Pharmaceutical Development Group.

Key findings

  • No adverse clinical signs were observed during the treatment period at any dose-level tested,
  • There were no effects on body weight and heart weight, no haemodilution or creatinine increase,
  • Electrocardiography did not reveal any undesirable effects related to IVA337 treatment,
  • Ophthalmological examinations did not reveal any undesirable effects related to IVA337 treatment,
  • Clinical pathology investigations (hematology, clinical biochemistry and urinalysis) did not reveal any undesirable effects related to IVA337 treatment.

Study Design

The objective of this study was to evaluate the safety profile of IVA337 following daily oral administration to cynomolgus monkeys over 52 weeks. Forty eight monkeys received a daily oral administration of IVA337 at doses of 100, 250 or 625 mg/kg/day or placebo for 52 weeks. On completion of the treatment period, designated animals were held for a 6-week treatment-free period in order to evaluate the reversibility of any findings.

Inventiva is currently conducting Phase IIb clinical trials with IVA337 in both NASH and SSc, and results are expected in the second half of 2018. In previous clinical studies with IVA337, the drug was well tolerated and safe, in particular there were no changes of creatinine blood levels, liver function tests, CPK, blood pressure, no signal of haemodilution or weight gain.

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 Presentation of Preclinical Results on IVA337 in NASH at the International Liver Congress™ 2017 (EASL)

Inventiva Announces Presentation of Preclinical Results on IVA337 in NASH at the International Liver Congress™ 2017 (EASL)

April 20, 2017

Daix (France), April 20, 2017 – 07:30 am CEST – Inventiva, a biopharmaceutical company developing innovative therapies, particularly to treat fibrosis, announced today the presentation of a poster on its lead drug candidate IVA337 at the 2017 International Liver Congress? annual meeting of the European Association for the Study of the Liver, currently being held in Amsterdam. The poster entitled “IVA337, a Pan-PPAR Agonist, Reduces NASH Features and Inhibits the Inflammasome in Murine Models of NASH” ;authored by Guillaume Wettstein, et al;, discussed the effect of IVA337 in two mechanistically different preclinical models of nonalcoholic steatohepatitis (NASH) and studied its effect on crucial pathways implicated in NASH and fibrosis development.

“The results of this preclinical study further confirm the potential of IVA337 as a treatment for NASH,” said Dr. Pierre Broqua, Chief Scientific Officer and Cofounder of Inventiva. “The findings demonstrate that IVA337 inhibits the development of NASH through the normalization of different metabolic parameters such as insulin-resistance, through activation of fatty acid ?-oxidation, and inhibition of the inflammasome known to be a trigger of liver inflammation and fibrosis.”

Study Design and Results

  1. C57bl/6 mice were fed for 3 weeks with methionine-choline deficient (MCD) diet and simultaneously treated with IVA337

  2. Foz/foz mice received a high fat diet (HFD) for 6 weeks to initiate NASH pathology and were kept under HFD alone or in combination with IVA337 for another 6 weeks.

IVA337 Activity in the Methionine-Choline Deficient Diet Model

IVA337 inhibits steatosis, inflammation, and the expression of pro-fibrotic genes, and improved global liver condition.

IVA337 Activity in the foz/foz Model

  • IVA337 has no effect on food intake or weight, quickly normalizes glycemia and improves glucose tolerance.

  • IVA337 restores insulin sensitivity

  • IVA337 improves NASH features – steatosis, ballooning, and inflammation were reduced compared to the HFD control group.

  • IVA337 inhibits the expression of pro-fibrotic genes

In both models, IVA337 demonstrated positive effects on the biological pathways that are altered during NASH development. Specifically, IVA337 decreased the expression of the inflammasome components such as caspase 1, IL-1 et IL-18 in both models, and activated the expression of genes regulating fatty acid catabolism. IVA337 also decreased the expression of inflammatory factors such as CCR2, CCL5 and NFKB.

About the International Liver CongressTM

The International Liver Congress? is the annual meeting of European Association for the Study of the Liver, and the flagship event in EASL’s educational calendar. The Congress is attended by scientific and medical experts from a broad range of fields including hepatology, gastroenterology, internal medicine, cell biology, transplant surgery, infectious diseases, microbiology and virology, pharmacology, pathology, radiology and imaging. Specialists share recent data, present studies and findings, and discuss the hottest topics on liver disease. The 2017 Congress is taking place April 19-23, 2017 at the RAI Amsterdam, Amsterdam, The Netherlands. The full EASL 2017 scientific program can be found at http://ilc-congress.eu

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 Hits Clinical Milestone with Enrollment of 100th Patient in IVA337 Phase 2b FASST Trial in Systemic Sclerosis (SSc)

Inventiva Hits Clinical Milestone with Enrollment of 100th Patient in IVA337 Phase 2b FASST Trial in Systemic Sclerosis (SSc)

April 10, 2017

> FASST Phase 2b Clinical Trial on Track to Complete Enrollment in 2nd Half of 2017

> Topline Results Anticipated in 2nd Half of 2018

Daix (France) April 10, 2017 – 06:00 pm CEST – Inventiva, a biopharmaceutical company developing innovative therapies, particularly to treat fibrosis, announced today that it has achieved an important milestone in its development of IVA337 for the treatment of systemic sclerosis (SSc), by enrolling the 100th patient into the Phase IIb FASST trial. The trial, which began in December 2015, is now 75% enrolled. The Company is currently on track to complete enrollment in the second half of 2017, with topline results expected to be available in the second half of 2018.

“We are pleased that the FASST study is proceeding on schedule, underscoring the interest we are seeing from physicians and patients in IVA337,” said Frédéric Cren, CEO and co-founder of Inventiva. “To deliver on the recruitment timelines is of major importance for Inventiva. With the opening of additional sites in new countries, we are confident that enrollment will be finalized by the end of this year, delivering the first results in the second half of 2018” said Pierre Broqua, CSO and co-founder.

“Systemic sclerosis is a fatal orphan disease with no approved treatment. Current treatment is directed mainly toward managing complications and providing symptomatic relief,” said Professor Chris Denton, Professor of Experimental Rheumatology at University College London and co-Principal Investigator of the FASST trial. “IVA337 has a unique mechanism of action and has demonstrated evidence of a therapeutic benefit in prior studies. It has the potential to be a true disease modifying agent and potentially highly effective treatment in this disease. I look forward to completing this important study and reporting results in 2018.”

“The anti-fibrotic activity of IVA337 has been demonstrated in preclinical studies, including recent experiments demonstrating anti-fibrotic activities in relevant models of lung and kidney fibrosis,” said Professor Yannick Allanore, Professor of Rheumatology at Ho?pital Cochin in Paris and co-Principal Investigator in the FASST trial. “These studies reinforce the rationale of developing IVA337 in the SSc population. The FASST clinical trial will generate further insight into the beneficial effects of IVA337 in humans, and I look forward to the results next year.”

FASST is a one-year randomized double-blind study designed to enroll up to a total of 132 patients at 50+ sites across eight European countries. Patients are being administered one of the two doses of IVA337 or placebo. The study protocol, approved by the European Medicines Agency (EMA), has been designed to demonstrate the beneficial effect of IVA337 on progression of SSc. The primary endpoint is a measure of the change in the modified Rodnan skin score, a measure of disease progression accepted by both FDA and the EMA. Inclusion criteria are based on a MRSS (Modified Rodnan Skin Score) between 10 and 25, and diffuse systemic sclerosis diagnosed from less than 3 years. Patients are permitted to continue with their ongoing treatments, including immunosuppressive therapies.

In November 2014, the European Medicines Agency (EMA) granted IVA 337 the orphan drug status for the treatment of systemic sclerosis. The orphan drug status provides certain advantages for the sponsor such as reduced procedure costs and ten years of commercial exclusivity.

“Much in line with this Phase IIb study in which patient enrollment is progressing very well, we are pursuing the execution of our clinical development plan we announced during our initial public offering in February. We remain on schedule to report important clinical results from mid-2018 in our three main indications, which are NASH, MPS VI and systemic sclerosis,” concluded Frédéric Cren, Inventiva’s CEO and co-founder.

About systemic sclerosis:

Systemic sclerosis is a rare and complex disease affecting the auto-immune system, the microvascular system and conjunctive tissues. This fibrotic disease mainly affects the skin, but also the lungs, the heart, the gastro-intestinal tract and the kidneys. Due to the progressive failure of different organs, systemic sclerosis is a severe disease with a high mortality rate. Once patients are diagnosed with systemic sclerosis, generally between the ages of 40 and 50, the median survival period is of 11 years. Close to 170,000 people suffer from systemic sclerosis, with women outnumbering men by a ratio of more than five to one1.

The disease owes its original name of scleroderma, which derives from the Greek words skleros (hard) and derma (skin), to the skin condition it provokes. The disease causes severe physical and psycho-social consequences; the former may be fatal for patients whose vital organs are affected. Deeper study of this skin fibrosis has led to its classification into two sub- categories, respectively called limited cutaneous systemic sclerosis and diffuse cutaneous systemic sclerosis. The latter is more serious and is targeted in the FASST trial.

To date, only symptomatic drugs with limited therapeutic effects are available in order to attenuate the consequences of fibrosis progression. However, they do not prevent, delay or reverse the disease’s devastating process.

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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