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.

In the wake of negative market reaction to Phase II data for its non-alcoholic steatohepatitis candidate, Intercept Pharmaceuticals Inc. is arguing that benefit seen in reducing fibrosis should more than counterbalance concerns about slightly increased LDL levels seen in the same study.

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