Zydus Lifesciences Limited, a pioneering global lifesciences company and its affiliated entities, collectively known as "Zydus," has announced the successful enrollment completion of the Phase 2b/3 EPICS IIITM trial for Saroglitazar Mg in patients suffering from Primary Biliary Cholangitis (PBC).

PBC is a rare autoimmune disease characterized by the gradual destruction of bile ducts in the liver, leading to the accumulation of bile, which can result in severe complications such as fibrosis, cirrhosis, the necessity for liver transplantation, or even mortality. This disease predominantly affects women, with a prevalence of 1 in 1,000 women over the age of 40, which is nine times higher than that in men.

Clinical manifestations of PBC include elevated levels of biochemical markers, notably alkaline phosphatase (ALP), bilirubin, and liver transaminases. Patients often experience debilitating symptoms such as pruritus (itching) and fatigue, making PBC a lifelong condition that necessitates ongoing management and treatment to slow its progression.

Saroglitazar Mg, a potent and selective peroxisome proliferator-activated receptor alpha and gamma dual agonist, holds promise as a potential therapeutic option for PBC. The results of the Phase 2 EPICS trial evaluating the safety, tolerability, and efficacy of Saroglitazar Mg were presented at the Liver Meeting® 2020, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), and published in the 'Journal of Hepatology'.

Professor Naga Chalasani, the Overall Principal Investigator for Saroglitazar Mg global development program and the David W. Crabb Chair in Gastroenterology and Hepatology at Indiana University School of Medicine, Indianapolis, USA, commended the Zydus team and investigators across three countries for achieving this significant milestone within a record timeframe. The outcomes of this pivotal trial have the potential to revolutionize treatment options for this challenging-to-treat and rare liver disorder.

The EPICS IIITM Phase 2(b)/3 trial, led by Lead Principal Investigator Professor Raj Vuppalanchi, aims to assess the efficacy and safety of Saroglitazar Mg in PBC patients who have not responded to standard first-line treatments.

Professor Raj emphasized the importance of addressing both liver health improvement and symptom alleviation in PBC patients. He expressed optimism that Saroglitazar Mg, at optimal dosages, would meet these needs with superior efficacy, safety, and tolerability compared to existing therapies, thereby enhancing the overall quality of life for patients. The medical community and patients alike eagerly anticipate the trial's outcomes, with hopes that Saroglitazar Mg will emerge as a primary therapy for PBC.

Chairman of Zydus Lifesciences Ltd., Mr. Pankaj Patel, underscored the significance of completing enrollment for the EPICS IIITM trial, expressing gratitude to all clinical collaborators and patients involved. He acknowledged the urgent need for new treatment modalities to mitigate disease progression in PBC patients and affirmed Zydus's commitment to collaborating with patient advocacy groups in advancing healthcare solutions.

It's noteworthy that Saroglitazar Mg is currently an investigational compound in the USA, pending approval by the U.S. Food & Drug Administration (USFDA) and the European Medicines Agency (EMA). The USFDA has granted 'Orphan Drug Designation' and 'Fast Track designation' to Saroglitazar Mg for the treatment of PBC patients. The EMA has designated 'Saroglitazar Magnesium' with Orphan status for the Treatment of Primary Biliary Cholangitis, entitling it to certain development incentives and regulatory benefits.

PBC is a progressive liver disease caused by the destruction of bile ducts, resulting in cholestasis. With an increasing prevalence and potentially fatal outcomes, there is an urgent need for therapies that effectively reduce biochemical markers and alleviate symptoms while maintaining safety and efficacy.