Zydus Therapeutics presents Phase 3 saroglitazar data at ACG 2026
- Composite biochemical response rate reached 60.7% in US subgroup vs 0% for placebo
- Treatment difference in US subgroup was Δ 60.7%, higher than Δ 41.6% in non-US subgroup
- Saroglitazar received FDA Priority Review and Fast Track Designation for PBC treatment
- Launch in the United States is planned for March 2027 if regulatory approval is granted
*this image is generated using AI for illustrative purposes only.
Zydus Lifesciences Limited subsidiary Zydus Therapeutics presented new post hoc analysis of its Phase 3 EPICS-III trial for investigational drug saroglitazar at the American College of Gastroenterology (ACG) 2026 Annual Meeting. The data highlighted a greater biochemical response in US patients compared to non-US subgroups in primary biliary cholangitis (PBC).
The presentation, delivered by Raj Vuppalanchi, MD, Global Principal Investigator for the study, focused on geographic consistency of treatment effects. The analysis compared 28 US patients treated with saroglitazar against 14 placebo-treated patients, and 69 non-US patients (from Argentina, Iceland, and Turkey) against 37 placebo-treated patients.
Biochemical Response Rates
The exploratory analysis revealed composite biochemical response rates were significantly higher with saroglitazar than placebo in both regions. In the US subgroup, the response rate was 60.7% for saroglitazar versus 0% for placebo. In the non-US subgroup, rates stood at 55.1% versus 13.5%.
A larger unstratified treatment difference was observed in the US subgroup (Δ 60.7%) compared to the non-US subgroup (Δ 41.6%). Alkaline phosphatase (ALP) normalization rates at Week 52 showed minimal variation between regions, with differences of 7.7% in the US and 9.6% in non-US patients.
| Metric | US Subgroup | Non-US Subgroup |
|---|---|---|
| Saroglitazar Patients | 28 | 69 |
| Placebo Patients | 14 | 37 |
| Composite Biochemical Response (Saroglitazar) | 60.7% | 55.1% |
| Composite Biochemical Response (Placebo) | 0% | 13.5% |
| Treatment Difference (Δ) | 60.7% | 41.6% |
What the Numbers Show
The data indicates a pronounced efficacy signal in the US cohort, where the treatment difference exceeded the non-US group by approximately 19 percentage points. While ALP normalization rates were comparable across geographies, the change from baseline in ALP levels was numerically greater in the US subgroup (Δ -166.2 U/L) relative to the non-US subgroup (Δ -104.7 U/L). This suggests that while the threshold for normalization was met at similar rates, the magnitude of biochemical improvement was more substantial in the US population.
Regulatory Status and Outlook
Saroglitazar is a novel Peroxisome Proliferator-Activated Receptor (PPAR) α/γ agonist currently under investigation for PBC. It has received Orphan Drug Designation, Fast Track Designation, and Priority Review from the U.S. Food and Drug Administration (FDA). The drug is not yet approved by the FDA.
Zydus Therapeutics plans to launch saroglitazar in the United States by March 2027 if approved. The EPICS-III trial was a multicenter, randomized, double-blind, placebo-controlled study involving 148 patients randomized in a 2:1 ratio. Saroglitazar was generally well tolerated, with adverse events balanced between treatment and placebo groups.
Historical Stock Returns for Zydus Life Science
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| +1.51% | -0.99% | +0.62% | +25.73% | +14.07% | 0.0% |
How will the FDA interpret the significant disparity in treatment efficacy between the small US subgroup and the larger non-US cohort during the Priority Review process?
What are the potential commercial implications for Zydus Therapeutics if the FDA requires additional US-specific clinical trials to validate the enhanced response seen in American patients?
How might competitor companies with approved PBC therapies adjust their market positioning strategies in anticipation of saroglitazar's potential launch in March 2027?
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