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Inventiva announces the positive recommendation of the fourth DMC of the NATiV3 Phase III clinical trial with lanifibranor in patients with MASH/NASH
InventivaInventiva(US:IVA) globenewswire.comยท2024-05-16 20:00

Core Viewpoint - The Data Monitoring Committee (DMC) has recommended the continuation of the NATiV3 Phase III clinical trial for lanifibranor without modifications, confirming its good safety profile based on a review of safety data from over 900 patients [1][2][3]. Company Overview - Inventiva is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for metabolic dysfunction-associated steatohepatitis (MASH/NASH) and other diseases with significant unmet medical needs [2][8]. - The company is advancing its lead product candidate, lanifibranor, which is a pan-PPAR agonist designed to target all three PPAR isoforms, contributing to its favorable tolerability profile observed in clinical trials [4][9]. Clinical Trial Details - The NATiV3 trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of lanifibranor in adult patients with biopsy-proven non-cirrhotic MASH/NASH and F2/F3 liver fibrosis, involving approximately 900 patients over a 72-week period [5][6]. - The DMC's review included safety data from more than 900 patients, with over 360 treated for more than 48 weeks and 80 for more than 72 weeks, supporting the trial's continuation [3][5]. Regulatory Status - Lanifibranor has received Breakthrough Therapy and Fast Track designations from the FDA for the treatment of MASH/NASH, which may expedite its development and review process [4][8].