Galmed’s Aramchol Meglumine shows improved results in Part 1 of AM-001 study

Galmed (GLMD) announced “positive” preliminary results from Part 1 of the Ph1 Bioavailability AM-001 Study of Aramchol Meglumine. Galmed has advanced Aramchol acid through six clinical trials establishing both its overall safety and its efficacy in treating NASH. The meglumine salt of Aramchol exhibits advantages over Aramchol acid, translating to higher bioavailability. In recognition of these benefits, Aramchol Meglumine received NCE patent protection extending until 2035. Previously, the FDA approved the transition from Aramchol acid to Aramchol Meglumine under a new IND. The only requirement for this transition was a bioavailability study to compare the two formulations. The AM-001 study was conducted in response to that FDA request and is also designed to help identify the doses best suited for advancing Aramchol Meglumine into Phase 2 studies. Part 2 of the study is anticipated to conclude in the second half of 2025. In Part 1 of AM-001, preliminary results demonstrate that a 400 mg dose of Aramchol Meglumine suspension achieved an area under the curve nearly double that of Aramchol acid tablets. Based on these outcomes, 200 mg once daily appears to be the optimal dose.