Clinical TrialJun 2, 2026, 07:06 PM
Zenas BioPharma's Obexelimab Phase 3 Meets Endpoints; BLA Submitted
AI Summary
Zenas BioPharma announced positive Phase 3 INDIGO trial results for obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD), meeting its primary and all key secondary endpoints with statistical significance. The data, presented at EULAR 2026 and published in the New England Journal of Medicine, showed obexelimab significantly reduced disease flares, glucocorticoid use, and related toxicities, with a favorable safety profile. The company submitted a Biologics License Application (BLA) to the FDA in May for obexelimab in IgG4-RD. Zenas also anticipates topline results from its Phase 2 SunStone SLE trial later this year.
Key Highlights
- Obexelimab Phase 3 INDIGO trial met primary and all key secondary endpoints.
- Biologics License Application (BLA) for obexelimab in IgG4-RD submitted to FDA in May.
- Obexelimab reduced IgG4-RD flare risk by 56% compared to placebo (p=0.0005).
- 73.2% of obexelimab-treated patients remained flare-free through Week 52 vs. 45.4% of placebo.
- Mean cumulative glucocorticoid rescue therapy use reduced by 65% with obexelimab (p=0.0042).
- Obexelimab showed lower incidence of Grade ">=3" treatment-emergent adverse events (11.3% vs. 23.7% placebo).
- Topline results for Phase 2 SunStone SLE trial expected in the fourth quarter of 2026.
Price Impact
More from ZBIO