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GENFIT: positive late-breaking Phase 2 data for elafibranor in Primary Sclerosing Cholangitis (PSC) to be presented by Ipsen at EASL Congress 2025
Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), April 28, 2025 - GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced that Ipsen will be presenting data from its late-breaking abstract on elafibranor, highlighting favorable safety profile and significant efficacy in Primary Sclerosing Cholangitis (PSC), at the European Association for the Study of
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[{"type":"text","content":"Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), April 28, 2025 - GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced that Ipsen will be presenting data from its late-breaking abstract on elafibranor, highlighting favorable safety profile and significant efficacy in Primary Sclerosing Cholangitis (PSC), at the European Association for the Study of the Liver (EASL) on May 10, 2025 at 11.15 CET.","length":547,"tagName":"p"},{"type":"text","content":"Efficacy results of Ipsen’s Phase 2 ELMWOOD trial (LB25222/OS089) showed that patients on elafibranor had significant dose-dependent reductions in alkaline phosphatase (ALP), with patients on elafibranor 80 mg and 120 mg having significant reductions at week 12 versus placebo (−103.2 U/L and −171.1 U/L vs +32.1 U/L; p < 0.0001), and improvements observed as early as week 4. Similar findings were seen in other biochemical liver parameters, including alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT), which are important biochemical markers of disease progression. Patients on elafibranor also had stabilization in Enhanced Liver Fibrosis (ELF), a non-invasive marker of liver fibrosis, versus patients on placebo at week 12. Additionally, patients on elafibranor 120 mg experienced improvements in pruritus compared with patients on placebo according to the Worst Itch Numeric Rating Scale (WI NRS) score (-0.96 vs -0.28; p<0.05).1","length":959,"tagName":"p"},{"type":"text","content":"Elafibranor, a 'first-in-class' molecule marketed and commercialized in the United States, the European Union and the UK by Ipsen under the trademark Iqirvo® since June 2024 for the treatment of Primary Biliary Cholangitis (PBC), was developed by GENFIT, from initial discovery to the conclusion of a 52-week Phase 3 clinical study. Ipsen licensed the exclusive worldwide rights (except China, Hong Kong, Taiwan and Macau) to elafibranor from GENFIT in 2021.","length":466,"tagName":"p"},{"type":"text","content":"Pascal Prigent, CEO of GENFIT, commented: “We continue to be very pleased with Ipsen’s commitment to developing elafibranor, and the results from the ELMWOOD Phase 2 trial further reinforce our belief in elafibranor’s potential to...