Galmed Pharmaceuticals Reports Top-Line Results From AM-001 Phase 1 Bioavailability Study, Demonstrating Enhanced Pharmacokinetic Profile Of Aramchol Meglumine Granules

Author: Benzinga Newsdesk | November 18, 2025 08:44am

The top-line results showed that bioavailability of Aramchol meglumine 400mg and 200mg granules is considerably greater, higher by 5-fold and 3-fold respectively, that of the Aramchol free acid 300mg tablets

The new unexpected PK profile allows for a once daily therapeutic regimen thus potentially improving long term adherence and expected to significantly reduce the drug cost of goods

RAMAT-GAN, Israel, Nov. 18, 2025 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on liver, cardiometabolic, and gastrointestinal oncology indications, today announced meaningful top-line results from Galmed's AM-001 Study, a Phase 1 Bioavailability (BA) Study of Aramchol meglumine.

The AM-001 study was designed to help identify the optimal doses for advancing Aramchol meglumine into the upcoming oncology Phase 2 studies planned for H1 2026. The study compared the relative BA of Aramchol meglumine granules to Aramchol free acid tablets in 30 healthy volunteers. The study results demonstrated that the BA of Aramchol from the Aramchol meglumine granules is considerably greater than that from Aramchol free acid tablets. The BA of 400mg and 200mg Aramchol meglumine granules were approximately 5-fold and 3-fold respectively, from that of the Aramchol free acid 300 mg tablets.

To date, Galmed has successfully advanced Aramchol through six clinical trials (up to Phase 3) enrolling 661 patients, establishing both its overall excellent tolerability, safety and efficacy in treating NASH (MASH) under the IND 505(b)1regulatory pathway. In addition, 82 healthy subjects to date have received Aramchol meglumine under a clinical trial application (CTA) in the United Kingdom.

Posted In: GLMD