Intercept Pharmaceuticals Inc. (NASDAQ: ICPT) shares jumped on Tuesday after the firm announced results for its Phase 3 Regenerate study of obeticholic acid (OCA) in patients with liver fibrosis due to nonalcoholic steatohepatitis (NASH).
In the primary efficacy analysis, the OCA 25 mg dosage met the primary endpoint of fibrosis improvement with no worsening of NASH at the planned 18-month interim analysis. Also, 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. However, 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.
It’s worth pointing out that this is the first and largest successful pivotal Phase 3 study in patients with liver fibrosis due to NASH.
Based on these results, Intercept intends to file for approval in the United States and Europe in the second half of 2019. OCA remains the only investigational drug to have received Breakthrough Therapy designation from the FDA for NASH with fibrosis.
Mark Pruzanski, M.D., president and CEO of Intercept, commented:
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. We are deeply grateful to the patients, investigators and study staff whose ongoing participation in Regenerate has brought us one step closer to delivering a much-needed therapeutic option to address the enormous unmet medical need in this population.
Shares of Intercept Pharmaceuticals were last seen up about 15% at $127.34, in a 52-week range of $58.03 to $133.74. The stock has a consensus price target of $147.95.
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