By Colin Kellaher

 

Intercept Pharmaceuticals Inc. on Thursday reported positive topline results from an interim analysis of its pivotal Phase 3 study of its proposed treatment of liver fibrosis due to nonalcoholic steatohepatitis, a chronic liver condition known as NASH.

The New York biopharmaceutical company said obeticholic acid 25-milligram met the agreed-upon primary endpoint of improvement in liver fibrosis without worsening of NASH at 18 months and showed double the response rate in reduction of fibrosis without worsening of NASH compared with placebo.

Intercept said that the analysis is the second in which obeticholic acid met the primary endpoint for the intent-to-treat population in the study, and that based on the results, it plans to resubmit its application seeking U.S. Food and Drug Administration approval of the drug.

The FDA in 2020 rejected Intercept's initial application for obeticholic acid, saying the company's efficacy data didn't sufficiently outweigh potential risks to support accelerated approval.

Intercept is slated to meet with the agency later this month to discuss the resubmission.

Trading in shares of Intercept, which closed Wednesday at $15.29, was halted premarket Thursday.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

July 07, 2022 08:14 ET (12:14 GMT)

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