BioCentury
ARTICLE | Clinical News

Galectin falls on NASH data for GR-MD-02

July 30, 2014 1:12 AM UTC

Galectin Therapeutics Inc. (NASDAQ:GALT) fell $8.84 (61%) to $5.50 on Tuesday after reporting data from the Phase I GT-020 trial of the company's GR-MD-02 to treat non-alcoholic steatohepatitis (NASH) with advanced hepatic fibrosis. In nine patients in the second cohort of the trial, 4 mg/kg IV GR-MD-02 on days 0, 21, 28 and 35 did not significantly improve exploratory secondary endpoints evaluating serum biomarkers of fibrosis and inflammation vs. placebo. The endpoints included FibroTest scores, an indirect biomarker of fibrosis; Enhanced Liver Fibrosis (ELF) scores, a marker of fibrotic tissue turnover; and levels of IL-6 or IL-8. The 4 mg/kg dose was well tolerated, with no serious adverse events; the primary endpoint of the dose-escalating trial is safety.

In March, Galectin said a 2 mg/kg dose of GR-MD-02 on days 0, 28, 35 and 42 did significantly reduce FibroTest scores and levels of IL-6 and IL-8 vs. placebo, but non-significantly reduced ELF scores vs. placebo. Galectin said differences in biomarker data between the cohorts may potentially be due to sampling dates. ...