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Galmed Pharmaceuticals Announces Successful Completion of End of Phase 2 Meeting With FDA and Plan for Start of Phase 3
TEL AVIV, Israel, April 9, 2019 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical
About this update from Galmed Pharmaceuticals Ltd.
[{"type":"text","content":"TEL AVIV, Israel, April 9, 2019 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) (\"Galmed\" or the \"Company\"), a clinical-stage biopharmaceutical company focused on the development of the liver targeted SCD1 modulator, Aramchol, an oral therapy for the treatment of nonalcoholic steatohepatitis (NASH) and fibrosis, announced today that the company has completed its End-of-Phase 2 meeting with the Food and Drug Administration (FDA) and reached general agreement on key aspects of the Phase 3/4 development and registration plan for Aramchol and on the pivotal registration study ARMOR. ARMOR is a Phase 3/4 multinational, multicenter, double-blind, placebo-controlled clinical study to evaluate the efficacy, safety and tolerability of Aramchol in subjects with NASH and fibrosis. \n\n \nGalmed previously announced results from its Phase 2b study which were subsequently presented at AASLD 2018. Efficacy and safety data from this study included notable effects on key registrational endpoints of NASH resolution and fibrosis improvement and favorable safety supporting initiation of the Phase 3/4 study. More recently, Galmed reported results from a study comparing once daily Aramchol 600 mg to twice daily 300 mg with a significant increase in exposure in the twice daily treatment arm and potential for additional efficacy with twice daily dosing. General agreement has been reached with FDA on key aspects of the ARMOR study including patient population, study endpoints, study dose and treatment duration. Galmed plans on submitting its study protocol and other design elements of its ARMOR trial to the FDA in the coming weeks with study commencement expected in the third quarter of 2019.\nGalmed plans on presenting an overview of its development plan of Aramchol at the NASH Summit in Boston on April 24, 2019.\nAbout Aramchol and Non-alcoholic Steatohepatitis (NASH)\nAramchol (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, inducing beneficial modulation of intra-hepatic lipid metabolism. Aramchol's ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating downregulation of the three key pathologies of NASH: steatosis, inflammation and fibrosis. The effect of Aramchol on fibrosis is mediated by downregulation of steatosis and directly on human collagen produci...