Inventiva secures a new patent for lanifibranor in China expanding the protection of its lead product candidate

• New patent granted by the CNIPA is directed at the use of lanifibranor for the treatment of several fibrotic diseases, including NASH, and expires in June 2035

• The patent expands the existing patent portfolio for lanifibranor in the world’s second largest pharmaceutical market¹

Daix (France), May 25, 2020 – Inventiva (Euronext: IVA), a clinical-stage biopharmaceutical company developing oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today announced that the China National Intellectual Property Administration (CNIPA) granted a new patent directed at the use of lanifibranor for the treatment of several fibrotic diseases in China until June 2035.

This new patent covers, among others, the use of the Company’s lead product candidate lanifibranor for the treatment of NASH, hepatic fibrosis, chronic renal failure and fibrotic pulmonary disorder. It thereby expands the protection of the molecule in China, the world’s second largest market for the pharmaceutical industry¹, and builds on a previously granted New Chemical Entity (NCE) patent.

Inventiva currently holds patents for lanifibranor in Asia, the United States and Europe.

Pierre Broqua, Ph.D., CSO and cofounder of Inventiva, said: "The granting of this patent is excellent news,  expanding our protection of lanifibranor in several fibrotic diseases, including NASH, in China, and supports the innovative approach that we are pursuing in this treatment area. It also enables us to strengthen our positioning in regions where the need for treatment of fibrotic diseases is very high. This milestone builds on the significant progress achieved in our NASH program throughout 2019 and follows the last patient visit in our Phase IIb NATIVE clinical trial for which we are expecting the release of topline results next month.”

About lanifibranor

Lanifibranor, Inventiva’s lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial vascular and 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 PPARa and PPARd, and a partial activation of PPAR?. 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 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 NASH, MPS and other diseases with significant unmet medical need.

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, 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. A Phase Ib/II clinical trial in children with MPS VI is currently under preparation following the release of positive results of the Phase IIa clinical trial in adult MPS VI patients at the end of 2019.

In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program. Furthermore, the Company has established a strategic collaboration with AbbVie in the area of autoimmune diseases. AbbVie has started the clinical development of ABBV-157, a drug candidate for the treatment of moderate to severe psoriasis resulting from its collaboration with Inventiva. This collaboration enables 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 collaboration.

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, as well as in clinical development. It also owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 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 

Inventiva

Frédéric Cren
Chairman & CEO
info@inventivapharma.com
+33 3 80 44 75 00

Brunswick Group
Yannick Tetzlaff / Tristan Roquet Montegon / 
Aude Lepreux
Media relations
inventiva@brunswickgroup.com
+33 1 53 96 83 83

Westwicke, an ICR Company
Patricia L. Bank
Investor relations
patti.bank@westwicke.com
+1 415 513 1284 

Important notice

This press release contains forward-looking statements, forecasts and estimates with respect to Inventiva’s clinical trials, clinical development plans, and anticipated future activities of Inventiva. 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 clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, or that candidates will receive the necessary regulatory approvals. 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 Universal Reference Document filed with the Autorité des Marchés Financiers on February 7, 2020 under n° D.20-0038 for additional information in relation to such factors, risks and uncertainties.

Except as required by law, 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 Market size measured in terms of sales. Source: IQVIA Institute: The Global Use of Medicine in 2019 and Outlook to 2023.

Attachment

• Inventiva - PR - Lanifibranor - New patent China - EN - 22052020 - VF