Intercept Thinks Fibrosis Effect Could Carry Its NASH Candidate
With Phase II data in its pocket showing a promising reduction in fibrosis, Intercept is eager to begin Phase III study of obeticholic acid in NASH. But regulators are still uncertain about what endpoints should be used and concerns about LDL levels in Phase II have driven the firm’s stock price down.
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A week after Gilead missed its primary endpoint in the first Phase III NASH trial, Intercept shows a statistically significant fibrosis benefit in Phase III with OCA. It plans to file for approval later this year.
Although GS-9674’s efficacy data don’t appear as promising as that for Intercept’s competing FXR agonist OCA, Gilead seems to be building an argument that its drug has a better combination of efficacy and safety.
Sponsors in the hotly pursued and yet untapped field of non-alcoholic steatohepatitis think that selection of different primary or co-primary endpoints could help differentiate their programs in the competitive space.