Galectin Hopes To Set Surrogate Endpoints For NASH Cirrhosis, Despite Trial Failure
Failure of small NASH cirrhosis study does not present much read-through to the larger class of NASH drugs in development. Galectin hopes its ongoing Phase IIb trial will validate its galectin-3 inhibitor in a more advanced disease state than most NASH candidates are pursuing.
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Although guidance appears to be free of surprises, US FDA once again made a push for sponsors to adopt seamless trial designs.
Company is moving its galectin-3 inhibitor into Phase III in non-alcoholic steatohepatitis patients with cirrhosis – a very advanced disease setting – and also to validate endpoints that don’t require liver biopsy.
Having failed to meet its primary endpoint in consecutive Phase II studies, Galectin hopes to move GR-MD-02 forward in NASH in patients with cirrhosis who have not developed esophageal varices.