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.