Inventiva , 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.