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MHRA Agrees with Galmed's Plan to use Aramchol meglumine in the Randomized Double-blind Placebo-Controlled Part of the Phase 3 ARMOR study
- MHRA agreement follows similar agreement from the FDA which allows Galmed to proceed with its proposed clinical studies with Aramchol meglumine in lieu of
About this update from Galmed Pharmaceuticals Ltd.
[{"type":"text","content":"- MHRA agreement follows similar agreement from the FDA which allows Galmed to proceed with its proposed clinical studies with Aramchol meglumine in lieu of Aramchol free acid without the need to repeat nonclinical and clinical studies\n\n\nTEL AVIV, Israel, Aug. 16, 2021 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) (\"Galmed\" or the \"Company\"), a clinical-stage biopharmaceutical company for liver, metabolic and inflammatory diseases announced today that the Medicines and Healthcare products Regulatory Agency (MHRA), the pharmaceuticals regulator in the UK, agreed with Galmed's plan to proceed with its proposed clinical studies with Aramchol meglumine in lieu of Aramchol free acid without the need to repeat nonclinical and clinical studies other than planned limited pharmacology studies relating to Aramchol meglumine. This follows similar agreement received from the FDA that was recently announced. \n \n \nAramchol 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 circulates in the blood as Aramchol. \nAllen Baharaff, Galmed co-founder and CEO commented: \"Our shift to Aramchol meglumine is part of our overall optimization strategy for our Phase 3 ARMOR study and the MHRA's agreement, which follows on the heels of the FDA's agreement, represents important validation of the steps that we are taking.\" Mr. Baharaff continued \"We are fully focused on the open label part of our Phase 3 ARMOR Study and look forward to presenting the results of the first one-third of patients during the fourth quarter of 2021.\"\nAbout Aramchol and Non-alcoholic Steatohepatitis (NASH)\nAramchol (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, liver targeted SCD1 modulator, developed as an oral therapy for the treatment of nonalcoholic steatohepatitis (\"NASH\") and fibrosis. 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 sta...