IVA - Inventiva lays out trial design for late-stage lanifibranor study in NASH

Clinical-stage biopharmaceutical company Inventiva (IVA) announces the details of the Phase 3 trial evaluating its lead drug candidate lanifibranor in NASH following the end-of-Phase 2 meeting with the FDA.Non-alcoholic steatohepatitis ((NASH)), is a fatty liver disease due to obesity.As part of the trial design the company aims to Seek U.S. accelerated approval and EU conditional approval for lanifibranor to be based on a 72-week histology analysis.The study will make use of a primary composite endpoint combining NASH resolution and fibrosis improvement.Endpoints of NASH resolution and no worsening of fibrosis, and improvement of fibrosis with no worsening of NASH will be included as key secondary endpoints.The trial will remain blinded after the pre-specified histological analysis and continue in ~2,000 patients until the occurrence of a pre-specified number of adverse liver-related clinical events, including progression to cirrhosis.Inventiva plans to initiate the trial in the first half of 2021.

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Inventiva lays out trial design for late-stage lanifibranor study in NASH