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Intercept Begins Phase 3 Trial of Obeticholic Acid for NASH
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Intercept Pharmaceuticals Inc. announced it has begun its phase 3 clinical trial that will be investigating obeticholic acid for the treatment of patients with nonalcoholic steatohepatitis and advanced liver fibrosis without cirrhosis.
Obeticholic acid (OCA), a bile acid analog and first-in-class agonist of the farnesoid X receptor, will be administered to up to 2,000 patients with NASH and stage 2 or stage 3 liver fibrosis from 300 clinical centers worldwide. The trial, known as REGENERATE, will determine the potential benefits of OCA treatment on liver-related and other clinical outcomes.
After 72 weeks of treatment, researchers will perform a pre-planned interim histology analysis in 1,400 patients. The two endpoints measured in the interim analysis include: fibrosis improvement with no worsening of NASH and NASH resolution with no worsening of fibrosis.
“We are excited to embark on the REGENERATE phase 3 trial of OCA in NASH and build on the exciting results from FLINT that demonstrated OCA’s potential to reverse advanced liver fibrosis in NASH patients,” Mark Pruzanski, MD, CEO and president of Intercept Pharmaceuticals, said in the release. “With REGENERATE, we hope to show that OCA treatment will prevent NASH patients with fibrosis from progressing to cirrhosis and cement its value as a breakthrough therapy for this underserved patient population.”
The FDA granted breakthrough therapy designation to OCA for NASH in January.
Disclosures: Pruzanski reports being employed by Intercept Pharmaceuticals.