Galmed announces 6 months delay to begin with PSC Ph 2a Study

Galmed Pharmaceuticals announced a delay of at least 6 months in the initiation of its Primary Sclerosing Cholangitis, or PSC, Ph 2a Study. In May Galmed announced the pivoting of its clinical program to evaluate the safety and efficacy of its lead compound, Aramchol meglumine, for the treatment PSC. All work was designed to ensure the initiation of a proof-of-concept Phase 2a study in the last quarter of 2023. Prior to the initiation of the Ph 2a study, Galmed had planned to complete a Ph1 pharmacokinetic study to determine the bioavailability of the newly improved Aramchol meglumine formulation and then submit a new IND application for Aramchol meglumine for PSC to the FDA. Due to the unexpected events of October 7th, Galmed no longer will be able to meet the original planned timelines of its Ph1 study. As new time estimates depend on timelines established by our US and European partners and vendors, Galmed currently estimates a delay of 6-9 months in the initiation of the Ph2a PSC Study.