Benzinga | Aug 2, 2021 07:31AM EDT

Galmed Pharmaceuticals Says FDA Agrees With Co's Plan To Use Aramchol Meglumine In Randomized Double-Blind Placebo-Controlled Part Of Phase 3 ARMOR 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.

Aramchol meglumine is an improved compound using a salt form of Aramchol that has significantly greater water solubility than the free acid and an NCE patent protection valid until December 2034. Aramchol meglumine contains the same active pharmaceutical ingredient (API) called Aramchol.

Prof. John Posner of the Centre for Pharmaceutical Medicine Research, King's College, London and Galmed Senior Advisor commented: "Clinical pharmacology studies in healthy volunteers demonstrated that administration of Aramchol meglumine doubled the systemic exposure of Aramchol compared with that after dosing Aramchol free acid. Exposure with once daily (QD) 383mg Aramchol meglumine oral dosage corresponds to that obtained with the existing twice daily (BID) 300mg Aramchol free acid form which is currently being evaluated in the Phase 3 ARMOR study. This allows future development of the QD regimen with a potential improvement in convenience and adherence".

Allen Baharaff, Galmed co-founder and CEO commented: "In addition to its longer IP protection until December 2034, the transition to Aramchol meglumine will benefit our patients in two meaningful ways: achieving the required exposure with 50% less API as well as significantly reducing our target marketing price once Aramchol is approved via the potential saving of ~50% of COGs." Mr. Baharaff continued " 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."