Zenas BioPharma Announces Upcoming Presentation of Results from Phase 3 INDIGO Registrational Trial of Obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD) at EULAR 2026 Congress

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- Safety and efficacy results from the Phase 3 INDIGO trial to be presented by Emanuel Della Torre, M.D., Ph.D., on Thursday June 4, 2026, at 2:45 PM GMT - WALTHAM, Mass., May 19, 2026 (GLOBE NEWSWIRE) -- Zenas BioPharma, Inc. (“Zenas,” “Zenas BioPharma” or the “Company”) (Nasdaq: ZBIO), a clinical-stage global biopharmaceutical company committed to being a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases, today announced that safety and efficacy outcomes from the Phase 3 INDIGO trial evaluating obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD) will be presented in an oral presentation at the upcoming European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, held from June 3-6, 2026, in London, England. INDIGO, the largest randomized, double-blind, placebo-controlled study conducted in IgG4-RD, met the primary endpoint demonstrating a highly statistically significant and clinically meaningful 56% reduction in the risk of IgG4-RD flare compared to placebo (HR 0.443; 95% CI 0.277–0.711; p=0.0005) during the 52-week randomized placebo-controlled period. Obexelimab also met and demonstrated highly statistically significant activity compared to placebo on all four key secondary endpoints: time to first investigator-determined flare requiring rescue therapy (p=0.0001), number of investigator- and AC-determined flares requiring rescue therapy (p=0.0008), proportion of patients achieving complete remission (p=0.0049), and cumulative glucocorticoid rescue therapy use (p=0.0042). Obexelimab was well tolerated with no new safety signals observed. Treatment-emergent adverse events (TEAEs) occurred in 97.9% vs 95.9% of participants (obexelimab vs placebo). Incidence of Grade ≥3 TEAEs was less with obexelimab (11.3% vs 23.7%), and the incidence of serious adverse events was 10.3% vs 18.6%. Infections occurred in 53.6% vs 62.9% of participants. Injection-site reactions were reported in 3.5% vs 2.3% of total patient doses. Hypersensitivity occurred in 16.5% vs 11.3% of participants. There were no deaths in the obexelimab group and one death (1.0%) in the placebo group.Details of EULAR Presentation:Title: Obexelimab, a B Cell Inhibitor, in IgG4-Related Disease: Results From the Phase 3 INDIGO TrialPresenting Author: Emanuel Della Torre, M.D., Ph.D., Associate Professor of Rheum...

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