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Intercept Pharma provides update on Phase III REVERSE trial of OCA for compensated cirrhosis due to NASH.

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Published:21st Dec 2021
Intercept Pharmaceuticals, Inc. announced that top-line data from its Phase III REVERSE trial will be delayed from previous guidance of near the end of the year and is now expected in the first quarter of 2022.

“Our teams continue to receive data and are working toward locking the database for our REVERSE study,” said Dr. M. Michelle Berrey, President of R&D and Chief Medical Officer. “As a result of the magnitude and complexity of these analyses and recognizing that we are relying on external parties for information and services, we expect these analyses, including the completion of biopsy readings and safety adjudications, to continue into the first quarter of 2022. There are no approved therapies for treatment of compensated cirrhosis due to NASH and we are focused on compiling this important data as soon as possible.”

REVERSE is the only active late-stage Phase III study in patients with compensated cirrhosis due to NASH, a serious disease for which there are no approved pharmacologic therapies. The liver biopsy samples from REVERSE are being evaluated utilizing a new consensus methodology.

Intercept is also using this new methodology to compile a new data package from the Phase III REGENERATE study in liver fibrosis due to NASH for a potential resubmission meeting with FDA in the first half of 2022, if the data supports it.

Condition: Non Alcoholic Steatohepatitis (NASH)
Type: drug

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