Core Insights - Inventiva has completed patient enrollment in its NATiV3 Phase 3 clinical trial, exceeding initial targets with 1009 patients in the main cohort and 410 in the exploratory cohort [1][6][4] - Topline results from the NATiV3 trial are expected in the second half of 2026, which could lead to the approval of lanifibranor as a new oral therapy for MASH [2][6] - The completion of enrollment supports the conditions for the second tranche of structured financing amounting to approximately €116 million [3] Company Overview - Inventiva is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for metabolic dysfunction-associated steatohepatitis (MASH) and other diseases with significant unmet medical needs [8][10] - The company is evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for adult patients with MASH [8][7] Clinical Trial Details - The NATiV3 trial is a randomized, double-blind, placebo-controlled study assessing the long-term efficacy and safety of lanifibranor in patients with biopsy-proven non-cirrhotic MASH and F2/F3 stage liver fibrosis [4][6] - The trial aims to evaluate several histological endpoints, including MASH resolution and improvement of fibrosis after 72 weeks of treatment [4] Product Information - Lanifibranor is designed to induce antifibrotic, anti-inflammatory, and beneficial vascular and metabolic changes by activating all three PPAR isoforms [5][7] - It is the only pan-PPAR agonist in clinical development for the treatment of MASH, with a favorable tolerability profile observed in clinical trials [7][5]
Inventiva announces completion of enrollment in the Phase 3 NATiV3 clinical trial of lanifibranor in patients with MASH and advanced fibrosis