GENFIT: positive late-breaking Phase 2 data for elafibranor in Primary Sclerosing Cholangitis (PSC) to be presented by Ipsen at EASL Congress 2025

Core Insights - GENFIT announced that Ipsen will present late-breaking data on elafibranor, demonstrating a favorable safety profile and significant efficacy in treating Primary Sclerosing Cholangitis (PSC) at the EASL Congress on May 10, 2025 [1][4] Efficacy Results - The Phase 2 ELMWOOD trial results showed that patients on elafibranor experienced significant dose-dependent reductions in alkaline phosphatase (ALP) levels, with reductions of −103.2 U/L and −171.1 U/L for the 80 mg and 120 mg doses respectively, compared to a placebo increase of +32.1 U/L (p < 0.0001) [2] - Improvements in other liver biochemical parameters, including alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT), were also observed, indicating a positive impact on disease progression [2] - Patients on elafibranor showed stabilization in Enhanced Liver Fibrosis (ELF) at week 12 compared to placebo [2] - The 120 mg dose of elafibranor led to significant improvements in pruritus, as measured by the Worst Itch Numeric Rating Scale (WI NRS), with scores of -0.96 versus -0.28 for placebo (p < 0.05) [2] Product Information - Elafibranor is a first-in-class oral peroxisome proliferator-activated receptor (PPAR) agonist, which has been marketed in the U.S., EU, and UK under the trademark Iqirvo® since June 2024 for Primary Biliary Cholangitis (PBC) [3][6] - The drug was developed by GENFIT and licensed to Ipsen in 2021, with exclusive worldwide rights except for certain regions in Asia [3][6] Company Overview - GENFIT is a biopharmaceutical company focused on rare and life-threatening liver diseases, with a strong emphasis on research and development [7] - The company has a diversified R&D portfolio, including assets targeting Acute-on-Chronic Liver Failure (ACLF) and other serious diseases [8] - GENFIT has established a diagnostic franchise, demonstrating its commitment to addressing unmet medical needs in liver disease [8]