Galmed pharmaceuticals initiates armor, a phase 3/4 registrational study of aramchol in subjects with nash and fibrosis

Galmed pharmaceuticals ltd. announced the initiation of its phase 3/4 armor clinical study to evaluate the efficacy and safety of aramchol in subjects with nash and fibrosis. this double-blind, placebo-controlled, global study will be conducted in approximately 185 sites in the u.s., europe, latin america and asia. the armor study will evaluate the efficacy and safety of aramchol in subjects with nash and fibrosis stages 2-3 who are overweight or obese and have prediabetes or type 2 diabetes. a total of 2,000 subjects will be randomized 2:1 to receive aramchol 300mg bid or matching placebo. the study is designed to consist of two parts. in the first part (histology-based) 1,200 subjects will be treated with aramchol or matching placebo for 52 weeks. the histology-based data will serve as the basis for the submission of a marketing authorization application under regulatory provisions of accelerated/conditional approval. in the second part (clinically-based), all subjects will continue with the same treatment assignment until study completion to confirm clinical efficacy. the armor study is designed based on the phase 2b results and fda guidance and is powered to meet the two alternative key histology-based endpoints: (i) nash resolution and no worsening of liver fibrosis, and (ii) fibrosis improvement without nash worsening. meeting one of these endpoints is expected to suffice for the study success of the first part.
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