Inventiva secures Japanese patent for lanifibranor

The Japanese Patent Office has granted approval to Inventiva’s patent application for lanifibranor, a treatment for cirrhosis. This patent, valid until November 8, 2039, enhances Inventiva’s intellectual property position in Japan, particularly for treating cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH) or non-alcoholic steatohepatitis (NASH). This development complements existing protection in the United States and further strengthens the company's patent portfolio for lanifibranor, which includes 20 patent families, 157 issued patents, and over 50 pending patent applications.

Pierre Broqua, Ph.D., Chief Scientific Officer and cofounder of Inventiva, expressed satisfaction with the Japan Patent Office's decision. He highlighted that this patent not only reinforces their intellectual property but also underscores lanifibranor’s potential in addressing significant unmet medical needs for patients with cirrhosis due to MASH/NASH. The new patent aligns with existing protections in the U.S. and other regions, bolstering lanifibranor’s standing as a leading candidate for treating MASH/NASH, cirrhosis, and other fibrotic diseases.

With up to 2.7% of Japan's population affected by MASH/NASH and no current treatments approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Japan represents a significant potential market for lanifibranor, pending approval. Inventiva has previously entered an exclusive licensing agreement with Hepalys Pharma, Inc. to develop and commercialize lanifibranor for MASH/NASH in Japan and South Korea.

Lanifibranor, Inventiva’s leading product candidate, is an orally-available small molecule that induces antifibrotic, anti-inflammatory, and beneficial vascular and metabolic changes by activating three peroxisome proliferator-activated receptor (PPAR) isoforms. Unlike other PPAR agonists that target one or two isoforms, lanifibranor is the only pan-PPAR agonist in clinical development for MASH/NASH, acting with moderate potency and balanced activation. This unique activation profile contributes to its favorable tolerability observed in clinical trials and pre-clinical studies. The U.S. Food and Drug Administration has granted Breakthrough Therapy and Fast Track designation to lanifibranor for treating MASH/NASH.

Inventiva is a clinical-stage biopharmaceutical company dedicated to developing oral small molecule therapies for MASH/NASH and other diseases with significant unmet medical needs. The company has a robust expertise in targeting nuclear receptors, transcription factors, and epigenetic modulation. Currently, Inventiva is advancing one clinical candidate, lanifibranor, which is in a pivotal Phase III clinical trial named NATiV3 for treating adult patients with MASH/NASH.

In addition to lanifibranor, Inventiva’s pipeline includes odiparcil, a drug candidate for treating adult MPS VI patients. However, the company has paused its clinical efforts on odiparcil to focus on lanifibranor and is reviewing further development options. Inventiva is also selecting a candidate for its Hippo signaling pathway program.

The company’s scientific team comprises approximately 90 experts in biology, medicinal and computational chemistry, pharmacokinetics, pharmacology, and clinical development. Inventiva owns a comprehensive library of around 240,000 pharmacologically relevant molecules, 60% of which are proprietary, alongside a wholly-owned research and development facility.

Inventiva is publicly traded on Euronext Paris and the Nasdaq Global Market in the United States under the ticker IVA.