BioCentury
ARTICLE | Clinical News

After NASH readout, Galmed looks to Phase III

June 12, 2018 6:33 PM UTC

Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) gained $10.54 (150%) to $17.59 on Tuesday after it said data from the Phase IIb ARREST trial showed that once-daily oral Aramchol arachidyl amino cholanoic acid led to disease improvements in patients with non-alcoholic steatohepatitis. Galmed said the data "strongly support" a Phase III trial of the synthetic conjugate of cholic acid and arachidic acid.

On a secondary endpoint in ARREST, Galmed reported that the higher of two doses of Aramchol improved the proportion of patients with NASH resolution without worsening of fibrosis at week 52 vs. placebo (16.7% vs. 5%, p=0.0514). CMO Tali Gorfine acknowledged to BioCentury that the results were not statistically significant, but noted that the higher dose of the therapy did significantly improve the overall proportion of patients with NASH resolution (19.2% vs. 7.5%, p=0.0462)...

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