Galmed: FDA agrees on use of improved compound in Phase 3 NASH study

 Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and inflammatory diseases announced today that the FDA agreed with its plan to use Aramchol meglumine (in lieu of Aramchol free acid) in its Phase 3 ARMOR study without the need to conduct additional nonclinical and clinical studies other than planned limited pharmacology studies relating to Aramchol meglumine.

Allen Baharaff, Galmed co-founder and CEO commented, "We consider the FDA's agreement a significant validation of Galmed's consistent efforts to maximize the potential of Aramchol in developing a NASH treatment. The transition to Aramchol meglumine is the final step in our drug product optimization which started with the move to the BID Aramchol free acid regimen (with it higher exposure than the once daily regimen used in our Phase IIb study).  The data on the optimization of treatment duration and potential Non-Invasive Tests (NITs) associated with NASH and fibrosis, which will be revealed from the ongoing open label part of the ARMOR study, is aimed at de-risking our clinical development plan while increasing the probability of success of Aramchol's ARMOR registrational Study."

https://www.prnewswire.com/news-releases/fda-agrees-with-galmeds-plan-to-use-aramchol-meglumine-in-the-randomized-double-blind-placebo-controlled-part-of-the-phase-3-armor-study-301345943.html