Zydus Therapeutics Reports Positive Topline Results from EPICS-III Phase 2(b)/3 Trial of Saroglitazar Magnesium in Patients with Primary Biliary Cholangitis

BusinessWire India

Pennington (New Jersey) [US] / Ahmedabad (Gujarat) [India], August 30: Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Ltd., a global innovation led healthcare company, today announced positive topline results from the pivotal EPICS-III Phase 2(b)/3 clinical trial. In this trial, the safety and efficacy of Saroglitazar, an investigational alpha/gamma Peroxisome Proliferator-Activated Receptor (PPAR) agonist, was evaluated for 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.

- Trial met the 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, the US-based innovation-focused specialty arm of Zydus Lifesciences Ltd,  intends to submit a U.S. regulatory application for Saroglitazar in the first quarter of 2026.

The trial met its primary composite endpoint, with a treatment difference in achieving a biochemical response of 48.5%, favoring Saroglitazar 1mg compared to those treated with placebo (P<0.001). Biochemical response was defined as alkaline phosphatase (ALP) <1.67x upper limit of normal (ULN), a ≥15% decrease of ALP relative to baseline, and total bilirubin ≤ ULN or direct bilirubin ≤ULN in patients with known Gilbert’s syndrome at 52 weeks. ALP and bilirubin are important predictors of PBC disease progression. The trial also met its key secondary endpoint, the proportion of subjects with complete normalization of ALP defined as ALP ≤ULN at 52 weeks. In the trial, Saroglitazar 1mg was generally well tolerated, with adverse events generally balanced between Saroglitazar 1mg-treated and placebo-treated patients.

Speaking on the development, Chairman of Zydus Lifesciences, Mr. Pankaj Patel said, “The EPICS-III results reinforce our commitment to advancing novel treatments for chronic liver disease — an area of high unmet medical need and growing global impact. Saroglitazar is the first PPAR alpha/gamma agonist to demonstrate positive Phase 3 data in patients with PBC and has the potential to bring real value to both patients and their healthcare providers who may need more options. As we look ahead, we’re excited about the potential of this investigational treatment and intend to discuss these results with regulatory agencies and plan to move forward with a regulatory submission to the U.S. Food and Drug Administration in the first quarter of 2026.”

“In clinical practice, we often see patients who continue to struggle despite being on standard therapy,” said Raj Vuppalanchi, MD, Professor of Medicine at Indiana University School of Medicine and Global Principal Investigator for the EPICS-III study. “Expanding our treatment options with new therapies could significantly change how we personalize care for individuals with PBC who haven’t responded to first-line treatment. We are thankful to the patients, their families, and the investigators whose participation made this study possible.”

The full data from the EPICS-III trial will be presented at a future scientific congress.

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