Zydus Therapeutics Reports Positive Topline Results from EPICS-III Phase 2(b)/3 Trial of Saroglitazar Magnesium in Patients with Primary Biliary Cholangitis
Zydus Therapeutics, a subsidiary of Zydus Lifesciences Ltd., has announced positive topline results from the EPICS-III Phase 2(b)/3 clinical trial. The trial evaluated the safety and efficacy of Saroglitazar, an investigational alpha/gamma Peroxisome Proliferator-Activated Receptor (PPAR) agonist, in the treatment of adult patients with Primary Biliary Cholangitis (PBC) who had an inadequate response or intolerance to ursodeoxycholic acid (UDCA), the current standard-of-care. The trial met its primary endpoint, with a statistically significant treatment difference in the percentage of patients achieving a clinically meaningful biochemical response with Saroglitazar compared to placebo. Saroglitazar was generally well tolerated, with overall adverse events generally balanced between Saroglitazar-treated and placebo-treated patients. Zydus Therapeutics plans to submit a U.S. regulatory application for Saroglitazar in the first quarter of 2026.
Key Highlights
- Zydus Therapeutics reports positive topline results from EPICS-III Phase 2(b)/3 trial of Saroglitazar Magnesium in patients with Primary Biliary Cholangitis.
- Saroglitazar met the primary composite endpoint with a treatment difference in achieving a biochemical response of 48.5% compared to placebo.
- Saroglitazar was generally well tolerated with adverse events generally balanced between Saroglitazar 1mg-treated and placebo-treated patients.
- Zydus Therapeutics plans to submit a U.S. regulatory application for Saroglitazar in the first quarter of 2026.
- Primary Biliary Cholangitis is a rare, progressive autoimmune disease which gradually destroys the bile ducts.