Galmed Pharmaceuticals successfully completed its End-of-Phase 2 meeting with the FDA discussing the future development of Aramchol. A general agreement was reached 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 designed to evaluate the efficacy, safety and tolerability of Aramchol in subjects with NASH and fibrosis. 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. Source
About NASH and Fibrosis
Non-Alcoholic Steatohepatitis is the most severe form of non-alcoholic fatty liver disease (NAFLD) and is characterized by the presence of an abnormal accumulation of fat in the liver which in some individuals can progress to liver cell injury (hepatocellular ballooning) and inflammation. As NASH evolves, over time it can result in excessive scarring in the liver (fibrosis), a natural response to injury which can lead to liver cirrhosis or liver cancer.
Aramchol (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 producing cells.
Aramchol has been granted Fast Track designation status by the FDA for the treatment of NASH.