Intercept Pharmaceuticals, Inc. ICPT announced positive topline results from a new interim analysis of its ongoing pivotal Phase 3 REGENERATE trial of OCA in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH).
The REGENERATE study is a Phase 3 clinical trial designed to investigate OCA in patients with liver fibrosis due to NASH. Safety was evaluated in 2,477 subjects who took at least one dose of study drug.
The study met the primary endpoint of achieving at least one stage of fibrosis improvement with no worsening of NASH at month 18 on liver biopsy compared with 9.6% of subjects on placebo.
Jerry Durso, President and Chief Executive Officer, commented : “Achieving a statistically significant histology endpoint has proven to be an extremely high bar in clinical trials for NASH. We are thrilled that OCA has demonstrated consistent improvement in fibrosis based on a second methodology and we now have two positive, statistically significant results for this primary endpoint from our pivotal REGENERATE trial. These results demonstrate the antifibrotic effect of OCA and are consistent with our belief that OCA can be an important treatment for people living with fibrosis due to NASH.”
Intercept is planning to resubmit new drug application (NDA) in liver fibrosis due to NASH, while a pre-submission meeting with FDA scheduled later this month.
Price Action : Intercept shares are trading down nearly 11 percent at $13.62 on Thursday in the pre-market session at the time of publication.
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