Galmed announced one-year results from the phase 2b trial, ARREST, published in the peer-reviewed journal Nature Medicine. The publication is a complete data analysis, including reduction in liver fat by imaging, improvements in liver histology and liver enzymes, and the safety profile of Aramchol.
The randomized ARREST Study enrolled 247 patients with NASH confirmed by liver biopsy. Patients were randomized 2:2:1 to receive Aramchol 400mg, 600mg, or placebo once daily. The primary endpoint was a decrease in hepatic triglycerides by magnetic resonance spectroscopy at 52 weeks with a dose of 600 mg of Aramchol. Although the primary endpoint of a reduction in liver fat did not meet the prespecified significance level, the observed safety and changes in liver histology and enzymes provide a rationale for SCD1 modulation as a promising therapy for NASH and fibrosis.
Based on this data, Galmed initiated the phase 3 ARMOR study to evaluate a higher dose of Aramchol. The multinational, multicenter, randomized, double-blind, placebo-controlled clinical study is evaluating the efficacy and safety of Aramchol 300mg twice daily in subjects with ...
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