A new patent issued in the United States by the USPTO protects the use of lanifibranor for the potential treatment of cirrhotic patients whose disease is at risk of progressing from the compensated to the decompensated stage
This patent strengthens and extends the intellectual property protection of lanifibranor in the United States, in particular for its use in patients with cirrhotic NASH
Daix (France), Long Island City (New York, United States), November 28, 2022
– Inventiva (Euronext Paris and Nasdaq: IVA) (the “Company”), a biopharmaceutical company specializing in the clinical development of small molecules administered orally for the treatment of patients with non-alcoholic steatohepatitis (NASH) and other diseases with a significant unmet medical need, announces today that the
United States Patent and Trademark Office
(USPTO) issued a patent (
U.S. Patent No. 11,504,380
) which protects the use of lanifibranor for the treatment of cirrhotic patients whose disease is at risk of progressing from the compensated to the decompensated stage. This patent will expire on November 8, 2039.
This patent strengthens the portfolio of patents that Inventiva has obtained in the United States for lanifibranor, the Company’s lead product candidate. This portfolio already included patents protecting the use of lanifibranor for the treatment of several diseases including NASH and fibrotic diseases. This new patent further extends the intellectual property protection of lanifibranor USA for its use in patients with cirrhotic NASH.
Pierre Broqua, Ph.D., Scientific Director and co-founder of Inventiva, said:
”
Obtaining this new patent is an important step in the development of lanifibranor for the treatment of a wide range of fibrotic diseases, in particular NASH. Inventiva’s strategy relies heavily on its expertise and R&D capabilities, and we believe this new patent confirms and supports the innovative approach we are taking to address certain unmet medical needs, including pre-cirrhotic NASH. and cirrhotic.
»
About Lanifibranor
Lanifibranor, Inventiva’s lead drug candidate, is an orally administered small molecule that works to induce anti-fibrotic, anti-inflammatory effects as well as positive vascular and metabolic changes by activating the three isoforms of peroxisome proliferators (“PPARs”). PPARs are well-known nuclear receptors that regulate epigenetic modulation. Lanifibranor is a PPAR agonist designed to moderately and equipotently activate all three PPAR isoforms, with balanced activation of PPARα and PPARδ, and partial activation of PPARγ. While there are other PPAR agonists that target one or two PPAR isoforms, lanifibranor is the most advanced pan-PPAR agonist in clinical development. The Company believes that the moderate and balanced pan-PPAR modulator profile of lanifibranor also contributes to the good safety and tolerability profile that has been observed in the clinical trials and preclinical studies in which it has been evaluated. In addition to the status of
FastTrack
“, the
Food and Drug Administration
(“FDA”) has granted the status of “
Breakthrough Therapy
to lanifibranor for the treatment of NASH.
About Inventiva
Inventiva is a biopharmaceutical company specializing in the research and development of orally administered small molecules for the treatment of patients with NASH, mucopolysaccharidosis (MPS) and other diseases with significant unmet medical needs. The Company has significant experience and expertise in the development of compounds targeting nuclear receptors, transcription factors and epigenetic modulation. Inventiva is currently developing a clinical candidate, has a portfolio of two preclinical programs and continues to explore other development opportunities to expand its portfolio.
Lanifibranor, Inventiva’s most advanced drug candidate, is currently being evaluated in the pivotal Phase III NATiV3 clinical study for the treatment of adult patients with NASH, a common and progressive chronic liver disease, for which it is there is currently no approved treatment.
Inventiva’s portfolio also includes odiparcil, a drug candidate for the treatment of adult patients with MPS type VI. As part of its decision to focus its clinical efforts on the development of lanifibranor, Inventiva has suspended its clinical efforts with odiparcil and is reviewing all available options to optimize its development. Inventiva is in the process of selecting a drug candidate in oncology as part of its program dedicated to the Hippo signaling pathway.
The Company has a scientific team of approximately 80 people with strong expertise in biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, as well as in clinical development. Inventiva has a chemical library of around 240,000 molecules, of which around 60% are exclusive to the Company, as well as its own laboratories and equipment.
Inventiva is listed on compartment C of the regulated market of Euronext Paris (Euronext Paris: IVA – ISIN: FR0013233012) and on the Nasdaq Global Market in the United States (symbol: IVA).
www.inventivapharma.com
.
contacts
Warning
This press release contains forward-looking statements. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. These statements include, but are not limited to, forecasts and estimates relating to Inventiva’s pre-clinical and clinical programs, including the NATiV3 Phase III clinical trial for the treatment of lanifibranor in NASH, the development potential and the regulatory journey for odiparcil, the information, analysis and impact that can be gathered through clinical trials, the potential therapeutic benefits of lanifibranor, the benefit of having received “Fast Track” status and “Breakthrough Therapy” by the US “FDA” for lanifibranor for the treatment of NASH or their impact on Inventiva’s ability to obtain regulatory approval, preclinical or clinical development plans, future activities, expectations, Company plans, growth and forecasts. Some of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “projects”, “plans”, “seeks”, “estimates”, “may”, “wants” and “continues” and other similar expressions. These statements do not relate to proven historical facts, but constitute projections, estimates and other forward-looking data based on management’s opinions, expectations regarding the potential commercial success and potential revenues of Inventiva’s drug candidates. These statements reflect the opinions and assumptions that were made on the date they were made. They are subject to known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those indicated or implied by such statements. Actual events are difficult to predict and may depend on factors beyond Inventiva’s control. With respect to the pipeline of product candidates, there can be no assurance that the results of clinical studies will be available on schedule, that future clinical studies will be launched as planned, or that these candidates will receive the necessary regulatory approvals. . Actual results may differ from future results described, implied or anticipated in such forward-looking statements due to a number of important factors, including that Inventiva is a clinical-stage company with no approved products and who does not have a history of revenue generated from the sale of products. These factors include, in particular, the significant losses generated since the creation of Inventiva, a limited operating history, the absence of income generated by the sale of Inventiva’s products, the need for additional funds to finance its operations. Inventiva’s future success also depends on the successful clinical development, receipt of regulatory approvals and subsequent commercialization of its current and future product candidates. Preclinical studies or prior clinical trials are not necessarily predictive of future results, and the results of Inventiva’s clinical trials may not support the reported benefits of Inventiva’s product candidates. Inventiva may experience significant delays in its clinical trials or Inventiva may fail to demonstrate the safety and efficacy of its products to the relevant regulatory authorities. Recruiting and retaining patients in clinical trials is a time-consuming and costly process that could be made more difficult or impossible by multiple factors beyond Inventiva’s control. Inventiva’s product candidates could cause adverse effects or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces significant competition, and the activities, preclinical studies and development programs Inventiva’s clinical development as well as timelines, its financial condition and results of operations could be materially affected by the COVID-19 pandemic and geopolitical events, such as the conflict between Russia and Ukraine, which could delay the initiation, recruitment and completion of Inventiva’s clinical trials on schedule or delaying them. Given these uncertainties, no representation is made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. In addition, forward-looking statements, forecasts and estimates speak only as of the date of this release. Readers are therefore cautioned not to place undue reliance on these forward-looking statements.
We invite you to refer to the Universal Registration Document for the financial year ended December 31, 2021 filed with the Autorité des marchés financiers on March 11, 2022 and to the financial report for the first half of 2022 for additional information concerning these factors, risks and uncertainties.
Subject to applicable regulations, Inventiva makes no commitment to update or revise the information contained in this press release. Inventiva cannot therefore be held liable for
consequences that may result from the use that would be made of these declarations.
Attachment
Inventiva – PR – Lanifibranor – New patent US – FR – 11 28 2022