#USA #Zydus Lifesciences #Pennington #Saroglitazar #PBC

Zydus Therapeutics Reports Encouraging Clinical Trial Results

Introduction
In a significant advancement for chronic liver disease treatment, Zydus Therapeutics, a subsidiary of Zydus Lifesciences Ltd., has announced favorable topline results from the pivotal EPICS-III Phase 2(b)/3 clinical trial. This trial evaluated Saroglitazar, an innovative alpha/gamma Peroxisome Proliferator-Activated Receptor (PPAR) agonist, on patients diagnosed with Primary Biliary Cholangitis (PBC) who previously did not respond adequately to the current standard treatment, ursodeoxycholic acid (UDCA).

Trial Overview
The EPICS-III trial met its primary endpoint, demonstrating a statistically significant treatment effect, with 48.5% of patients receiving Saroglitazar achieving a clinically meaningful biochemical response when compared to those on placebo (P<0.001). In assessing the trial's outcomes, a biochemical response was defined through alkaline phosphatase (ALP) levels and total bilirubin counts at the 52-week mark. With such measures being key indicators of PBC progression, these findings underscore Saroglitazar's potential to transform patient care.

Safety and Tolerability
In terms of safety, Saroglitazar was generally well tolerated among participants. Notably, the occurrences of adverse events were comparable between patients on Saroglitazar and those on placebo, suggesting a balanced safety profile. This tolerance is vital as it encourages further research and potential regulatory approvals.

Future Outlook
Zydus Therapeutics is gearing up to submit a regulatory application for Saroglitazar to the U.S. FDA by the first quarter of 2026. The Chairman of Zydus Lifesciences, Mr. Pankaj Patel, emphasized the company's commitment to exploring and advancing novel treatments for chronic liver diseases, an area with significant unmet medical needs. He stated, “Saroglitazar is the first PPAR alpha/gamma agonist to demonstrate promising Phase 3 results in PBC patients, potentially offering vital new options for both patients and healthcare providers.”

Expert Insights
Dr. Raj Vuppalanchi, an esteemed Professor at Indiana University School of Medicine and the Global Principal Investigator for the EPICS-III study, expressed hope regarding the expanded treatment options that Saroglitazar could provide. He noted that many patients continue to struggle despite existing therapies, making it crucial to personalize care with the introduction of innovative treatments.

The Battle Against Primary Biliary Cholangitis
PBC is a rare autoimmune condition characterized by the gradual destruction of bile ducts, ultimately leading to serious liver complications such as fibrosis, cirrhosis, and even liver failure. Patients may experience severe symptoms like intense itching and fatigue, making effective treatments necessary.

About Saroglitazar
Saroglitazar is a unique PPAR alpha/gamma agonist designed to target bile acid toxicity and liver inflammation—two leading factors in PBC disease progression. With Orphan Drug Designation and Fast Track Designation already awarded by the FDA, Saroglitazar is on track to become a pivotal component in the treatment landscape.

Conclusion
As Zydus Therapeutics prepares for an extensive regulatory review of Saroglitazar, the promising trial results give hope to many suffering from Primary Biliary Cholangitis. The full data from the EPICS-III trial is expected to be shared at an upcoming scientific conference, further illuminating Saroglitazar's potential role in chronic liver disease management. This pivotal research may well usher in a new era of treatment options for patients and their healthcare providers alike.