Zydus completes EPICS-IIITM trial enrollment for Saroglitazar Mg in PBC treatment

New Delhi: Zydus Lifesciences Limited has successfully completed the enrolment for the Phase 2b/3 EPICS-III trial of Saroglitazar Mg in patients with Primary Biliary Cholangitis (PBC).

PBC is a rare autoimmune disease that progressively damages the bile ducts, leading to bile accumulation in the liver, which can result in severe complications such as fibrosis, cirrhosis, and even death. PBC is identified by elevated levels of certain biochemical indicators, notably alkaline phosphatase (ALP), bilirubin, and liver transaminases. Common clinical manifestations encompass severe itching (pruritus) and fatigue. Since PBC is a lifelong ailment, treatment primarily involves medication to control and decelerate its advancement.

With a significantly higher prevalence in women, which is 9 times the rate of men, PBC poses a substantial health risk, affecting approximately 1 in 1,000 women over the age of 40.

Saroglitazar Mg, a potent and selective peroxisome proliferator-activated receptor alpha and gamma dual agonist, holds promise as a treatment for PBC. Previous Phase 2 trial results published in the ‘Journal of Hepatology’ demonstrated its efficacy as a second-line therapy for PBC, showcasing a Best-in-Disease Profile.

The completion of enrolment for the EPICS-III trial is a significant milestone in evaluating the safety and efficacy of Saroglitazar Mg in PBC patients who are unresponsive to conventional first-line treatments.

Led by Principal Investigator Prof Raj Vuppalanchi, the late-stage clinical program aims to assess the potential of Saroglitazar Mg in improving liver health, “Patients with PBC often look for treatments that not only improve liver health but also alleviate associated symptoms like itching and fatigue ultimately enhancing overall quality of life. There is growing optimism that Saroglitazar Mg at optimal dosage will address these needs with better efficacy, safety and tolerability compared to existing options. Both patients and medical community are eagerly awaiting the outcomes of this trial. I have strong hope that Saroglitazar Mg will establish itself as a primary therapy, significantly improving the daily lives of individuals suffering with PBC.”

Chairman of Zydus Lifesciences, Pankaj Patel, expressed gratitude to the clinical collaborators and patients involved in the trial, emphasizing, “The conclusion of enrolment marks an important milestone for the for EPICS-III Phase 2b/3 trial and we would like to thank all our clinical collaborators and patients. There is a high need for new treatment options to reduce the risk of disease progression in patients living with PBC and we are looking forward to working with patient advocacy groups.”

The results of the EPICS-III trial are eagerly awaited by both patients and the medical community, with hopes that Saroglitazar Mg will emerge as a primary therapy for PBC, addressing the unmet needs of patients and providing a ray of hope for improved outcomes in managing this rare condition.