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Galmed Announces Results from First-in-Man Pharmacokinetics Study of Oral Formulation of Aramchol Meglumine (AM); 400mg AM Increases Bioavailability by ~500% in Comparison to Aramchol Free Acid (AA) 300mg
Results from Study AM-001 mark a pivotal advance through the transition to a once daily lower 400mg dose of AM enabling:Production of GMP clinical batch for
About this update from Galmed Pharmaceuticals Ltd.
[{"type":"text","content":"Results from Study AM-001 mark a pivotal advance through the transition to a once daily lower 400mg dose of AM enabling:Production of GMP clinical batch for Galmed's upcoming clinical trialsSolidification and prolongation of Aramchol's IP protectionPotential reduction in drug CoGs by ~50%Improvement in patients' convenience and compliance upon potential commercializationRAMAT-GAN, Israel, May 14, 2026 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD) (\"Galmed\" or the \"Company\"), a clinical-stage biopharmaceutical company for liver disease and GI oncological therapeutics, announced today major milestone results from a Phase 1 PK study in healthy subjects (Study AM-001). The overall objective of the study was to identify the dose of Aramchol meglumine (AM) administered once daily that produces similar exposure to Aramchol from 300mg Aramchol free acid (AA) tablets dosed twice daily. Single doses of AM granules for oral suspension of 400 mg and 200mg were evaluated and compared to AA 300mg tablet. The study demonstrated that the bioavailability of Aramchol from the Aramchol meglumine granules for oral suspension is considerably greater (approximately 5-fold and 3-fold respectively) than that from Aramchol free acid tablets. An additional PK study (AM-003) comparing AM 400mg tablets once daily with AA 300mg tablets twice daily is ongoing. \nAramchol down-regulates stearoyl CoA desaturase 1 (SCD1) in hepatocytes and in hepatic stellate cells (HSC's) and other tissues including various cancers. Metabolic-dysfunction associated steatohepatitis (MASH) (previously called non-alcoholic steatohepatitis (NASH)) is a common serious type of fatty liver disease often leading to cirrhosis, liver failure and sometimes to hepatocellular carcinoma. In Phase 2 and Phase 3 (open label part) clinical trials 600mg Aramchol reduced liver fat, attenuated steatohepatitis and demonstrated robust anti-fibrotic effects. To date ~ 600 adults have received single or multiple doses of Aramchol free acid, including ~240 healthy subjects and 360 patients with MASH.Allen Baharaff, Galmed's Co-founder and CEO, commented: \"A once daily lower dose of Aramchol meglumine is advantageous for compliance as monotherapy or in combination with other MASH candidates. Aramchol is currently being evaluated in multiple pre-clinical studies to overcome drug resist...