Core Viewpoint - The initiation of the clinical development program for lanifibranor in Japan marks a significant step for Inventiva and Hepalys in addressing metabolic dysfunction-associated steatohepatitis (MASH) in a market where approximately 2.7% of the population is affected by this condition [4][9]. Company Overview - Inventiva is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for MASH and other diseases with unmet medical needs. The company is currently evaluating lanifibranor in a pivotal Phase 3 clinical trial [11]. - Hepalys Pharma, Inc. is a private biopharmaceutical company dedicated to developing novel therapeutics for liver disease, with a focus on lanifibranor and other compounds for Asian markets [6]. Clinical Development - The Phase 1 clinical trial for lanifibranor in Japan involves 32 subjects who will be randomly assigned to four cohorts, receiving the drug once daily for 14 days [2]. - The trial is part of an exclusive licensing agreement between Inventiva and Hepalys, which outlines that Hepalys will conduct and finance all necessary trials in Japan and South Korea for new drug applications [3]. Market Potential - The partnership aims to introduce lanifibranor to the Japanese market, where there is a significant patient population suffering from MASH, thus presenting a potential opportunity for the companies if the drug is approved [4][5]. Product Information - Lanifibranor is a pan-PPAR agonist designed to induce antifibrotic, anti-inflammatory, and beneficial metabolic changes by activating all three PPAR isoforms. It is the only pan-PPAR agonist in clinical development for MASH [10]. - The FDA has granted Breakthrough Therapy and Fast Track designations to lanifibranor, indicating its potential therapeutic benefits for MASH [10].
Inventiva and Hepalys Pharma, Inc. announce the initiation of the clinical development program of lanifibranor in Japan with the dosing of the first participant in Phase 1 trial