#India #Ahmedabad #Saroglitazar #PBC #Zydus Therapeutics

Zydus Therapeutics Presents Significant Findings from the EPICS-III Trial

Zydus Therapeutics Inc., a part of Zydus Lifesciences Limited, recently showcased crucial analyses from their pivotal Phase 3 EPICS-III trial at the 2026 Annual Meeting of the American College of Gastroenterology (ACG). The focus was on the investigational drug Saroglitazar, which has not yet received FDA approval. This study gathered insights into the drug's effectiveness for patients suffering from Primary Biliary Cholangitis (PBC) who either did not respond adequately to or could not tolerate Ursodeoxycholic acid (UDCA).

Background of the EPICS-III Trial

The EPICS-III trial is designed as a Phase 2(b)/3 multicenter, randomized, double-blind, placebo-controlled study. It aimed to assess the efficacy and safety of Saroglitazar in treating patients who have shown inadequate responses to UDCA. Over 148 patients were enrolled in this study, which focused on optimizing dose selection before launching the Phase 3 component.

The recent analysis, presented by Dr. Raj Vuppalanchi from Indiana University School of Medicine, delved into whether Saroglitazar's treatment effects were uniform across different geographic areas, specifically comparing outcomes in the U.S. to those in other countries such as Argentina, Iceland, and Turkey.

Key Findings from the Analysis

The data revealed compelling results. Among the U.S. patients who received Saroglitazar, 60.7% showcased a biochemical response versus none in the placebo group. In non-U.S. regions, the figures were similarly promising, with a 55.1% response in the Saroglitazar cohort compared to 13.5% for placebo. Overall, the treatment showed a notable unstratified difference of 60.7% in the U.S. subgroup against 41.6% in the broader non-U.S. subgroup.

Furthermore, while the ALP normalization treatment differences at 52 weeks did not show significant divergence between the two cohorts, the U.S. patients did exhibit noteworthy ALP reductions from baseline, showcasing a more pronounced impact of Saroglitazar in this demographic. Specifically, changes indicated that U.S. patients experienced more substantial decreases in ALP levels compared to their international counterparts.

The Importance of These Findings

Understanding the variable responses based on geography is crucial, as noted by Dr. Vuppalanchi. These findings shed light on the overarching outcomes from the EPICS-III trial and could help streamline future approaches to treating PBC where individual responses to drugs can significantly vary.

Zydus Therapeutics is currently awaiting FDA review for Saroglitazar and if successful, it aims to launch this promising treatment in the U.S. by March 2027. The ongoing findings from this and further trials will undeniably shape its clinical trajectory.

Conclusion

As a leading biopharmaceutical company focusing on innovative treatments for rare liver disorders, Zydus Therapeutics remains committed to understanding and improving the lives of patients with PBC. These recent discoveries from the EPICS-III trial affirm their dedication to advancing healthcare solutions through rigorous research and an unwavering commitment to delivering transformative treatments. For further updates, visit Zydus Therapeutics at www.zydustx.com.