The Phase IIa trial was a multi-center, randomized, double-blind, placebo-controlled trial of aramchol in 60 Non-alcoholic fatty liver disease, or NAFLD, and Non-Alcoholic Steato-Hepatitis, or NASH, patients in 12 centers in Israel. The trial demonstrated that aramchol may reduce liver fat in a dose dependent manner, as evidenced by a statistically significant reduction of liver fat over a three-month treatment period of once-daily 300 mg doses of aramchol, and may induce positive trends of changes in several metabolic parameters.
The trial’s primary efficacy end point was a reduction in liver fat content, without consideration of inflammation or fibrosis. The secondary efficacy end points measured differences between the aramchol-treated group and the placebo group with respect to alterations of liver enzyme levels, levels of adiponectin, homeostasis model assessment scores, and endothelial function. All endpoints were met and there were no notable changes in biochemical, hematological, cardiovascular or other safety parameters, or any observable serious or drug-related adverse events in the 58 patients who completed the trial either during the three-month treatment period or during the subsequent recovery period.
The company said that, later this year, it intends to begin a multi-center, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb clinical trial of aramchol in 240 NASH patients who also suffer from obesity and insulin resistance. Shares are up 2.98% at $8.98 with a 52-week range of $6.38 – $18.73.
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