Drug maker Zydus Lifesciences Ltd on Friday (August 29) announced that its US-based innovation-focused specialty arm, Zydus Therapeutics, reported positive topline results from the pivotal 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, 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.
The trial met its primary composite endpoint, with a statistically significant treatment difference of 48.5% in achieving a clinically meaningful biochemical response, favouring saroglitazar 1mg over placebo (P<0.001).
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Biochemical response was defined as alkaline phosphatase (ALP) <1.67x the upper limit of normal (ULN), a ≥15% decrease in ALP from baseline, and total bilirubin ≤ ULN or direct bilirubin ≤ ULN in patients with known Gilbert’s syndrome at 52 weeks. ALP and bilirubin are recognised as important predictors of disease progression in PBC.
Saroglitazar 1mg also met the key secondary endpoint in the study — demonstrating a significantly higher proportion of subjects achieving complete normalisation of ALP, defined as ALP ≤ ULN at 52 weeks.
Saroglitazar was generally well tolerated, with adverse events balanced between the saroglitazar-treated and placebo-treated groups. Based on these results, Zydus Therapeutics intends to submit a US regulatory application for saroglitazar in the first quarter of 2026.
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Pankaj Patel, Chairman of Zydus Lifesciences, 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.”
Shares of Zydus Lifesciences Ltd ended at ₹980.75, up by ₹3.85 or 0.39%, on the BSE today (August 29).
