Intercept Increases Chance Of Success In NASH Without Significant Delay
Ocaliva could now qualify for accelerated approval in NASH by meeting either of two Phase III co-primary endpoints, whereas the trial initially was designed for success on both measures.
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Obeticholic acid failed to separate from placebo in a Phase III study of non-alcoholic steatohepatitis patients with cirrhosis, but Intercept said it still plans to refile an NDA for pre-cirrhotic NASH by year’s end.
Gilead presented early data for combinations of its three mechanisms in NASH, but analysts noted the findings may undercut its lead candidate selonsertib. Plus EASL takeaways for Genfit, NGM and Madrigal.
After otherwise successful Phase II NASH trial showed Ocaliva can increase a patient's LDL cholesterol levels, Intercept hopes a study in NASH patients who use atorvastatin will show this effect is manageable.