Intercept's Revised NASH Trial Improves Prospects

 
• By Joseph Haas
  
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The pivotal REGENERATE study of Ocaliva now can succeed if either of two co-primary endpoints is achieved. Intercept also will use a new "objective" definition of NASH resolution in the study.

The longstanding uncertainty over pivotal endpoints for non-alcoholic steatohepatitis (NASH) took another turn as Intercept Pharmaceuticals Inc. – broadly seen as leading the space with the first drug candidate into Phase III – revised the protocols for its pivotal REGENERATE study, lowering the bar for success, reducing the number of patients needed for an interim analysis that could lead to accelerated approval and adopting a new "objective" definition for the resolution of NASH.

Intercept announced Feb. 10 that instead of trying to meet co-primary endpoints of resolution of NASH with worsening of fibrosis...

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