Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) rose sharply Tuesday, after the company disclosed that its pivotal Phase 3 REGENERATE study of obeticholic acid patients with NASH-related liver fibrosis met primary endpoint.
The New York-based Intercept,, a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that in the primary efficacy analysis, once-daily OCA 25 mg met the primary endpoint of fibrosis improvement (≥1 stage) with no worsening of NASH at the planned 18-month interim analysis (p=0.0002 vs. placebo).
In the primary efficacy analysis, a numerically greater proportion of patients in both OCA treatment arms compared to placebo achieved the primary endpoint of NASH resolution with no worsening of liver fibrosis, but this did not reach statistical significance.
As agreed with the U.S. Food and Drug Administration (FDA), in order for the primary objective to be met, the study was required to achieve one of the two primary endpoints.
Said CEO Mark Pruzanski, "We are thrilled to report the first positive registrational Phase 3 study results in patients with NASH, a devastating disease that is on track to become a leading cause of liver transplant in coming years.
"The topline REGENERATE data we are reporting today support our belief that OCA will become the first approved medicine for those living with liver fibrosis due to NASH."
Tuesday’s news release went on to say that, based on these results, Intercept intends to file for approval in the U.S. and Europe in the second half of 2019.
Shares were galvanized $13.77, or 12.4%, to $124.59
