Inventiva secures a new patent in Japan, expanding the IP protection of its lead product candidate lanifibranor
- Japanese Patent Office approved Inventiva's patent application relating to the use of lanifibranor for the treatment of cirrhosis.1
- This patent strengthens Inventiva's intellectual property with respect to lanifibranor in Japan for the indication cirrhosis, including cirrhosis due to MASH/NASH.
Daix (France), Long Island City (New York, United States), July 25, 2024 – Inventiva (NASDAQ:IVA) ("Inventiva" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of patients with metabolic dysfunction-associated steatohepatitis ("MASH"), also known as non-alcoholic steatohepatitis ("NASH"), and other diseases with significant unmet medical needs, today announced that the Japan Patent Office ("JPO") has approved Inventiva's patent application No. JP 2019-203498, protecting the use of lanifibranor for the treatment of patients with cirrhosis. This new patent will be valid until November 8, 2039, excluding any potential patent term adjustments or extensions that may provide additional protection.
The patent granted by the JPO expands the intellectual property protection of lanifibranor for use in patients with cirrhosis including patients with cirrhosis due to MASH/NASH, complementing the protection previously granted by the United States Patent and Trademark Office2. The approval of this patent further strengthens Inventiva's patent portfolio for lanifibranor, the Company's lead product candidate. To date, this portfolio is composed of 20 patent families directly owned by Inventiva, including 157 issued patents and more than 50 pending patent applications. The Company's patent portfolio, with respect to lanifibranor, includes patents and patent applications directed to the product lanifibranor, the methods of treatment, the combination therapy, the processes, the formulations and diagnostic methods.
Pierre Broqua, Ph.D., Chief Scientific Officer and cofounder of Inventiva, stated: "We are delighted by the Japan Patent Office's decision to grant this patent for lanifibranor. We believe this patent not only reinforces our intellectual property position but also highlights lanifibranor's potential in addressing significant unmet medical needs in patients with cirrhosis, in particular cirrhosis due to MASH/NASH. This new patent complements our existing patent protection in the United States, and other regions, and strengthens lanifibranor's position as a leading candidate for the potential treatment of MASH/NASH, cirrhosis and other fibrotic diseases."
With up to 2.7%3 of Japan's population with MASH/NASH and no treatment approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Inventiva believes Japan could become an important market for lanifibranor, if approved. As previously disclosed, Inventiva entered into an exclusive licensing agreement with Hepalys Pharma, Inc. in September 2023 to develop and commercialize lanifibranor for the potential treatment of MASH/NASH in Japan and South Korea.
About lanifibranor
Lanifibranor, Inventiva's lead product candidate, is an orally-available small molecule that acts to induce antifibrotic, 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 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 for the treatment of MASH/NASH. Inventiva believes that lanifibranor's moderate and balanced pan-PPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and pre-clinical studies to date. The U.S. Food and Drug Administration has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of MASH/NASH.
About Inventiva
Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of oral small molecule therapies for the treatment of patients with MASH/NASH and other diseases with significant unmet medical need. The Company benefits from a strong expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation. Inventiva is currently advancing one clinical candidate, has a pipeline of two preclinical programs and continues to explore other development opportunities to add to its pipeline.
Inventiva's lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of adult patients with MASH/NASH, a common and progressive chronic liver disease.
Inventiva's pipeline also includes odiparcil, a drug candidate for the treatment of adult MPS VI patients. As part of Inventiva's decision to focus clinical efforts on the development of lanifibranor, it suspended its clinical efforts relating to odiparcil and is reviewing available options with respect to its potential further development. Inventiva is also in the process of selecting a candidate for its Hippo signaling pathway program.
The Company has a scientific team of approximately 90 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, and clinical development. It 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 B of the regulated market of Euronext Paris ((ticker: IVA, OTC:IVEVF) and on the Nasdaq Global Market in the United States (ticker: IVA). www.inventivapharma.com
Contacts
| Inventiva Pascaline Clerc, PhD EVP, Strategy and Corporate Affairs [email protected] +1 202 499 8937 | Brunswick Group Tristan Roquet Montegon / Aude Lepreux / Julia Cailleteau Media relations [email protected] +33 1 53 96 83 83 | Westwicke, an ICR Company Patricia L. Bank Investor relations [email protected] +1 415 513-1284 |
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These statements include, but are not limited to, forecasts and estimates with respect to Inventiva's intellectual property and intellectual property strategy, including potential patent terms and related adjustments or extensions, pre-clinical programs and clinical trials, including design, duration, timing, recruitment costs, screening and enrollment for those trials, including the ongoing NATiV3 Phase III clinical trial with lanifibranor in MASH/NASH, clinical trial data releases and publications, the information, insights and impacts that may be gathered from clinical trials, the potential therapeutic benefits of Inventiva's product candidates, including lanifibranor, the estimated market size and patient population for lanifibranor in Japan, expectations with respect to clinical development and commercialization of lanifibranor by Hepalys Pharma, Inc., including with respect to regulatory approvals, expectations with respect to the benefits of the agreement with Hepalys Pharma, Inc., potential regulatory submissions, approvals and commercialization, Inventiva's pipeline and preclinical and clinical development plans, the expected benefit of having received Breakthrough Therapy Designation and Fast Track designation to lanifibranor for the treatment of MASH/NASH, including its impact on the development and review timeline of Inventiva's product candidates, the potential development of and regulatory pathway for odiparcil, and future activities, expectations, plans, growth and prospects of Inventiva and its partners. 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Please refer to the Universal Registration Document for the year ended December 31, 2023, filed with the Autorité des Marchés Financiers on April 3, 2024, and the Annual Report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission (SEC) on April 3, 2024 for other risks and uncertainties affecting Inventiva, including those described under the caption "Risk Factors", and in our future filings with the SEC. Other risks and uncertainties of which Inventiva is not currently aware may also affect its forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. All information in this press release is as of the date of the release. 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 Inventiva's lead product candidate, lanifibranor, is currently in a pivotal Phase III clinical trial, NATiV3, for the treatment of adult patients with MASH/NASH, a common and progressive chronic liver disease.
2 inventivapharma.com/wp-content/uploads/2022/11/Inventiva-PR-Lanifibranor-New-patent-US-EN-11-28-2022.pdf
3 Eguchi Y, Wong G, Lee EI, Akhtar O, Lopes R, Sumida Y. Epidemiology of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in Japan: A focused literature review. JGH Open. 2020 May 5;4(5):808-817.
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