ZBIO reports a 56% reduction in flare risk in Phase 3 trial for Immunoglobulin G4-Related Disease therapy obexelimab.
Zenas BioPharma Inc. (NASDAQ:ZBIO) announced positive Phase 3 INDIGO trial results for obexelimab, showing a 56% reduction in flare risk for Immunoglobulin G4-Related Disease compared to placebo. The study also demonstrated significant decreases in glucocorticoid use and related toxicities.
The trial, the largest ever conducted for this disease, found over 73% of treated patients remained flare-free through 52 weeks. Safety profiles were comparable to placebo. Results were presented at the EULAR 2026 Congress and published in the New England Journal of Medicine.
Following these findings, Zenas submitted a Biologics License Application to the FDA in May. The company continues to advance its pipeline, with additional data expected from a Phase 2 trial for systemic lupus erythematosus later this year.