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Intercept Increases Chance Of Success In NASH Without Significant Delay

 
• By Joseph Haas

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.

Liver

Intercept Pharmaceuticals Inc. is making a pair of protocol changes to the pivotal trial of its Ocaliva (obeticholic acid or OCA) in non-alcoholic steatohepatitis (NASH), but it maintains those will increase the odds of producing successful data, without pushing back the timelines in any material way.

Despite the protocol changes announced Feb. 10, Intercept said it should complete enrolling sufficient patients (about 750) by mid-2017 for an interim efficacy evaluation, likely in 2019, that could lead to accelerated approval in NASH

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