New promising results on lanifibranor to be presented at The Liver Meeting® 2019 New study shows the potential of lanifibranor for the treatment of advanced chronic liver disease The study has been selected for an oral presentation at The Liver Meeting® 2019 Inventiva will host a KOL meeting focusing on lanifibranor as a potential treatment for NASH on the sidelines of the congress Daix (France), August 26, 2019 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of diseases in the areas of fibrosis, lysosomal storage disorders and oncology, today announced that its abstract on the evaluation of lanifibranor in a pre-clinical model of cirrhosis has been selected by the American Association for the Study of Liver Diseases (AASLD) for an oral presentation at the upcoming The Liver Meeting® 2019 in Boston, Massachusetts, USA (November 8-12, 2019). The study, which was led by Prof. Jordi Gracia-Sancho1, aimed at evaluating lanifibranor in a pre-clinical model of cirrhosis. The results clearly showed that lanifibranor exerts beneficial effects producing a marked regression of liver fibrosis and decreasing portal hypertension. In addition, lanifibranor strongly reduced hepatic inflammation, and improved the phenotype of liver sinusoidal endothelial cells and hepatic stellate cells. These promising results demonstrate the potential of lanifibranor for the treatment of advanced chronic liver disease. The abstract, entitled “The pan-PPAR agonist lanifibranor improves portal hypertension and hepatic fibrosis in experimental advanced chronic liver disease”, will be presented on November 10, 2019 as part of The Liver Meeting® 2019 (see details below). In parallel, Inventiva will host a KOL meeting focusing on lanifibranor as a potential treatment for NASH with the participation of Dr. Manal Abdelmalek2, Dr. Pierre Bedossa3, Dr. Kenneth Cusi4 and Dr. Sven Francque5. This meeting will take place from 8:00 am – 9:30 am (local time) on November 11, 2019 at the Mandarin Oriental Boston hotel (Bar Bouloud), Boston, Massachusetts, USA. Pierre Broqua, Chief Scientific Officer and cofounder of Inventiva, commented: “These results are excellent news for lanifibranor and demonstrate its potential for the treatment of advanced chronic liver disease. They mark an important step in the development of lanifibranor and follow our previous findings that already showed the beneficial effects of our product candidate in pre-clinical models relevant to NASH. All these results reinforce our confidence in the unique mechanism of action of lanifibranor and its potential to treat NASH patients. I am looking forward to the upcoming The Liver Meeting® 2019 as well as the KOL meeting hosted by Inventiva to present our recent findings and to further discuss lanifibranor’s potential for the treatment of NASH.”The details of Inventiva’s oral presentation at The Liver Meeting® 2019 are as follows: Abstract title: “The pan-PPAR agonist lanifibranor improves portal hypertension and hepatic fibrosis in experimental advanced chronic liver disease”Publication number: 0063Session title: Parallel 6: Novel Therapeutics for NASHDate: Sunday, November 10, 2019Session time: 10:30 am (local time)Presentation time: 11:00 am (local time)Location: Auditorium, John B. Hynes Memorial Convention Center, Boston, Massachusetts, USAEvent: The Liver Meeting® 2019 About lanifibranor Lanifibranor, Inventiva’s lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial metabolic changes in the body by activating all three peroxisome proliferator activated receptor (“PPAR”) isoforms, which are well characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only pan PPAR agonist in clinical development. Inventiva believes that lanifibranor’s moderate and balanced pan PPAR binding profile contributes to the favorable safety and tolerability profile that has been observed in clinical trials and pre clinical studies to date. Inventiva is currently evaluating lanifibranor in a Phase IIb clinical trial for the treatment of non-alcoholic steatohepatitis (“NASH”), a common and progressive chronic liver disease, for which there is currently no approved therapy. About Inventiva Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of diseases with significant unmet medical needs in the areas of fibrosis, lysosomal storage disorders and oncology. Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently advancing two clinical candidates – lanifibranor and odiparcil – in non-alcoholic steatohepatitis (“NASH”) and mucopolysaccharidosis (“MPS”), respectively, as well as a deep pipeline of earlier stage programs. Lanifibranor, its lead product candidate, is being developed for the treatment of patients with NASH, a common and progressive chronic liver disease. Inventiva is currently evaluating lanifibranor in a Phase IIb clinical trial for the treatment of this disease for which there are currently no approved therapies. Inventiva is also developing odiparcil, a second clinical‑stage asset, for the treatment of patients with MPS, a group of rare genetic disorders. The Company is currently investigating odiparcil in a Phase IIa clinical trial for the treatment of patients with the MPS VI subtype. In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program. The Company has established two strategic partnerships with AbbVie and Boehringer Ingelheim in the areas of autoimmune diseases and idiopathic pulmonary fibrosis (“IPF”) respectively. AbbVie has started the clinical development phase of ABBV‑157, a drug candidate for the treatment of moderate to severe psoriasis resulting from its collaboration with Inventiva. Both collaborations entitle Inventiva to receive milestone payments upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on any approved products resulting from the partnerships. The Company has a scientific team of approximately 70 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology a well as in clinical development. It also owns an extensive library of approximately 240,000 pharmacologically relevant molecules, around 60% of which are proprietary, as well as a wholly‑owned research and development facility. Inventiva is a public company listed on compartment C of the regulated market of Euronext Paris (Euronext: IVA – ISIN: FR0013233012). www.inventivapharma.com Contacts InventivaFrédéric CrenChairman & CEOinfo@inventivapharma.com+33 3 80 44 75 00 Brunswick GroupYannick Tetzlaff / Tristan Roquet MontegonMedia firstname.lastname@example.org+33 1 53 96 83 83 LifeSci AdvisorsMonique KosseInvestor email@example.com+1 212 915 3820 Important NoticeThis 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 12, 2019 under n° R.19-006 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. 1 Liver Vascular Biology Research Group, IDIBAPS Biomedical Research Institute & CIBEREHD. Barcelona, Spain. 2 Professor of Medicine in the Division of Gastroenterology and Hepatology at Duke University and Director of the NAFLD Clinical Research Program at Duke University. 3 Professor of Pathology and Director of the Department of Pathology of the Hôpital Beaujon (Paris, France). 4 Chief of the Division of Endocrinology, Diabetes & Metabolism in the Department of Medicine at the University of Florida. 5 Professor of Medicine at the Faculty of Medicine and Health Sciences at the University of Antwerp and Chairman of the Department of Gastroenterology and Hepatology.
Inventiva – PR – ASSLD The Liver Meeting – EN – 26 08 19