Clinical TrialMay 19, 2026, 07:07 AM
Zenas BioPharma Obexelimab Phase 3 INDIGO Trial Meets Primary Endpoint
AI Summary
Zenas BioPharma announced positive safety and efficacy results from its Phase 3 INDIGO trial for obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD). The trial met its primary endpoint, showing a highly statistically significant 56% reduction in IgG4-RD flare risk compared to placebo. Obexelimab also met all four key secondary endpoints and was well tolerated with no new safety signals. These results will be presented at the EULAR 2026 Congress on June 4, 2026. The company also expects topline results from a Phase 2 trial for Systemic Lupus Erythematosus in Q4 2026.
Key Highlights
- Obexelimab Phase 3 INDIGO trial met primary endpoint for IgG4-RD.
- Demonstrated 56% reduction in IgG4-RD flare risk vs. placebo (p=0.0005).
- Met all four key secondary endpoints with high statistical significance.
- Obexelimab was well tolerated with no new safety signals observed.
- Lower incidence of Grade ">=3" TEAEs (11.3% vs 23.7% for placebo).
- Lower incidence of serious adverse events (10.3% vs 18.6% for placebo).
- Results to be presented at EULAR 2026 Congress on June 4, 2026.
- Phase 2 trial for Systemic Lupus Erythematosus topline results expected Q4 2026.
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