Ipsen Reports P-II (ELMWOOD) Trial Data of Elafibranor for Primary Sclerosing Cholangitis (PSC)
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- Ipsen has reported P-II (ELMWOOD) trial data assessing elafibranor (80 or 120mg) vs PBO in 68 PSC pts for 12wks.; 96wks. OLE study evaluating elafibranor (120mg) is ongoing
- Trial demonstrated favorable safety & tolerability (1EP) at Wk. 12, with elafibranor 80 or 120mg vs PBO showing TRAEs 68.2%, 78.3% vs 69.6% pts, respectively
- Elafibranor also showed improved 2EPs incl. dose-dependent ALP reductions at Wk. 12 (−103.2 & −171.1 vs +32.1 U/L), with effects seen as early as 4wks., plus improvements in ALT & GGT. Pts had ELF stabilization, with 120mg depicting pruritus relief (WI-NRS score: −0.96 vs −0.28); data to be presented at EASL 2025
Ref: Ipsen | Image: Ipsen
Related News:- Ipsen’s Kayfanda (Odevixibat) Gains the CHMP’s Positive Opinion to Treat Cholestatic Pruritus in Alagille Syndrome (ALGS)
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
