Galmed Pharmaceuticals (GLMD) announced positive preliminary results from Part 1 of the Ph1 Bioavailability AM-001 Study of Aramchol Meglumine. The company said initial findings suggest that the new Aramchol Meglumine formulation offers higher bioavailability than Aramchol free acid and that a once-daily, oral 200 mg dose is likely to be optimal for future trials.
Previously, the FDA approved the transition from Aramchol acid to Aramchol Meglumine under a new IND. The 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. Part 2 of the study is anticipated to conclude in the second half of 2025.
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