DSMB recommends continuation of Galectin's Phase IIb NASH trial

Galectin Therapeutics Inc. (NASDAQ:GALT) said a DSMB recommended for the third time continuation of the Phase IIb NASH-CX trial evaluating galactoarabino-rhamnogalacturonate (GR-MD-02) in non-alcoholic steatohepatitis (NASH) patients with cirrhosis. Galectin said the DSMB found no safety concerns among the 68% of enrolled patients who had completed the trial at the time of review. Top-line data from the trial are expected in December.

The double-blind, U.S. trial has enrolled 162 patients to receive 2 or 8 mg GR-MD-02 every other week or placebo for 52 weeks. Galectin said 11 patients have dropped out. The primary endpoint is reduction in hepatic venous pressure gradient (HVPG). Secondary endpoints include liver biopsy with qualitative fibrosis staging and fibrosis quantification, liver stiffness, liver metabolism and biomarkers...