Saroglitazar shows stronger results in U.S. patients with primary biliary cholangitis

A post hoc regional analysis of the phase 3 EPICS-III trial revealed that U.S. patients with primary biliary cholangitis (PBC) experienced stronger biochemical and pruritus responses to saroglitazar magnesium compared to non-U.S. patients. Presented at the ACG Annual Scientific Meeting, the findings suggest that while the drug outperformed placebo in both groups, the treatment benefit was numerically larger among American participants.

Saroglitazar, a dual PPAR-alpha/gamma agonist developed by Zydus Therapeutics, works by targeting bile acid homeostasis and reducing cholestatic inflammation. The analysis compared 42 U.S. participants with 106 non-U.S. participants, with baseline characteristics largely similar between groups.

By the Numbers:

• Composite biochemical response (placebo-adjusted): 60.7% in U.S. vs. 41.6% in non-U.S. patients
• Mean ALP reduction at week 52: –166.2 U/L (U.S.) vs. –104.7 U/L (non-U.S.)
• ALP normalization rates: 7.1% (U.S.) vs. 8.7% (non-U.S.) — similar between groups
• 5-D itch score improvement at week 24: –4.4 (U.S.) vs. –2.8 (non-U.S.)

Why it matters: These regional insights could help clinicians better anticipate treatment outcomes for U.S. PBC patients and support saroglitazar's potential role as a meaningful therapeutic option in a disease with limited treatment choices.