Galectin Offers Subgroup Approach For Struggling NASH Candidate
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.
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Other NASH registration trails have targeted fibrosis, but Galectin's mostly-resolved discussions with US FDA will allow the belapectin program to focus of signs and symptoms of the disease.
Galectin faces a dual challenge - do its planned trial well and trust that the study design will lead the galectin-3 inhibitor belapectin to a niche position in NASH.
Although guidance appears to be free of surprises, US FDA once again made a push for sponsors to adopt seamless trial designs.