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July 8, 2014
10:36 EDTGLMDGalmed reports publication of aramchol Phase IIa trial in medical journal
Galmed Pharmaceuticals announced the recent publication of the results of its Phase IIa clinical trial of aramchol in the peer-reviewed Clinical Gastroenterology and Hepatology Journal. The trial manuscript provides the full report of the Phase IIa trial, which was completed in January 2012 and presented at the 47th Annual Meeting of the European Association for the Study of the Liver in 2012. The Phase IIa 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. 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. Later this year, Galmed 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.
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