Galectin's NASH candidate misses in Phase IIb

Galectin Therapeutics Inc. (NASDAQ:GALT) said galactoarabino-rhamnogalacturonate (GR-MD-02) missed the primary endpoint of reducing hepatic venous pressure gradient (HVPG) in the double-blind, U.S. Phase IIb NASH-CX trial to treat patients with non-alcoholic steatohepatitis (NASH) cirrhosis.

On the 161-patient trial's primary endpoint, 2 and 8 mg/kg doses of GR-MD-02 given every other week non-significantly reduced HVPG from baseline to week 54 by 0.2 and 0.4 mmHg, respectively, vs. an increase of 0.4 mmHg for placebo. Both doses did meet the secondary endpoint of improving hepatocyte ballooning on liver biopsy vs. placebo (p=0.03 and p=0.04, respectively)...