Inventiva, a biopharmaceutical company in the clinical-stage, has announced that its patent application No. JP 2019-203498 for the use of lanifibranor in treating cirrhosis has been approved by the Japan Patent Office (JPO). This patent is set to remain valid until November 8, 2039, with potential for extension through patent term adjustments.
This new JPO patent fortifies Inventiva’s intellectual property rights for lanifibranor, specifically for cirrhosis treatment, including cases caused by MASH/NASH. This complements existing protection previously granted by the United States Patent and Trademark Office.
Currently, Inventiva’s lanifibranor patent portfolio consists of 20 patent families, encompassing 157 issued patents and over 50 pending applications. This comprehensive portfolio covers the product itself, treatment methods, combination therapies, processes, formulations, and diagnostic methods.
Pierre Broqua, Ph.D., Chief Scientific Officer and co-founder of Inventiva, expressed enthusiasm about the JPO’s decision, stating, “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.”
Japan, where up to 2.7% of the population suffers from MASH/NASH and no treatments have been approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), represents a significant potential market for lanifibranor, pending approval. In September 2023, Inventiva entered an exclusive licensing agreement with Hepalys Pharma, Inc. to develop and commercialize lanifibranor for MASH/NASH treatment in Japan and South Korea.
Lanifibranor is an orally-available small molecule that promotes antifibrotic, anti-inflammatory, vascular, and metabolic benefits by activating all three isoforms of peroxisome proliferator-activated receptors (PPARs).
As a pan-PPAR agonist, lanifibranor targets PPARa, PPARd, and partially PPAR? isoforms, offering a balanced and moderate activation profile that distinguishes it from other PPAR agonists, which typically target only one or two isoforms. This balanced activation is believed to contribute to lanifibranor’s favorable tolerability, as observed in clinical trials and pre-clinical studies.
The U.S. Food and Drug Administration has also recognized lanifibranor’s potential by granting it Breakthrough Therapy and Fast Track designations for MASH/NASH treatment. As reported by pharmabiz.com, Inventiva continues to focus on developing oral small molecule therapies to address MASH/NASH and other diseases with high unmet medical needs.