Intercept ‘lowers the bar’ on its pivotal PhIII OCA study for NASH
Intercept CEO Mark Pruzanski has redrawn the rules on their pivotal Phase III study of obeticholic acid (OCA).
After talks with the FDA, Pruzanski said today that investigators can reduce their target on the number of patients needed for an interim analysis of the FXR agonist in 2019, dropping the target from 1,400 to 750. And the agency has signed off on changing the endpoint from fibrosis and NASH resolution to either fibrosis or NASH while accepting an objective definition of NASH resolution to clarify success.
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