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Intercept's NASH liver fibrosis drug shows promise at Phase 3

Published on 20/02/19 at 11:12am

Intercept Pharmaceuticals has publicised promising new data on the efficacy of Ocaliva (obeticholic acid) in the treatment of liver fibrosis due to nonalcoholic steatohepatitis (NASH), sending the company’s shares up by 32%.

The findings showed that the 25mg dose of Ocaliva met the study’s primary endpoint of fibrosis improvement (≥1 stage) with no worsening of NASH at the planned 18-month interim analysis. It was also noted that a greater proportion of patients in both arms of the study met the primary endpoint of NASH resolution with no worsening of liver fibrosis compared to placebo, but not to a statistically significant degree.  

“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,” said Dr Mark Pruzanski, President and Chief Executive Officer of Intercept. “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.”

Intercept confirmed its intention to submit regulatory applications in both Europe and the US on the back of these data in the second half of this year.

“Patients with significant fibrosis due to NASH are at the greatest risk of progression to severe liver-related complications, such as liver failure and death, and fibrosis is considered the strongest predictor of liver-related mortality in this population,” added Dr Zobair M Younossi, Professor and Chairman of the Department of Medicine at Inova Fairfax Medical Campus, Professor of Medicine at Virginia Commonwealth University, Inova Campus and the Chair of the REGENERATE Steering Committee. “I am very encouraged by these results that demonstrate OCA’s ability to significantly improve fibrosis in patients with advanced disease. As the first successful pivotal trial in NASH, REGENERATE is an important advancement for the liver community.”

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