Galectin’s NASH Phase III Trial Will Use Surrogate Measures Of Esophageal Varices
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.
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Our infographic offers a snapshot of the trial endpoints and mechanisms of action of the compounds at the front of the race to treat the enormous NASH market.
Recently filed NDA for obeticholic acid relies on US FDA's specified endpoints for treatment of fibrosis, but European standards are less clear cut, the company acknowledges.
Analysts call Intercept sell-off overblown in wake of EASL presentation of fuller Phase III data for OCA in NASH. But while depth is added to efficacy argument, pruritus concerns possibly worsen.