Zenas BioPharma Announces Positive Results from Phase 3 INDIGO Registrational Trial of Obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD)

– Obexelimab met the primary endpoint demonstrating a clinically meaningful and highly statistically significant 56% reduction in risk of IgG4-RD flare –

– Obexelimab also met and demonstrated statistically significant activity on all four key secondary efficacy endpoints –

– Obexelimab was well tolerated and no new safety signals were observed –

– Zenas anticipates submitting a Biologics License Application (BLA) to the FDA in the second quarter of 2026 and a Marketing Authorization Application (MAA) to the EMA in the second half of 2026 –

Excerpt from the Press Release:

WALTHAM, Mass., Jan. 05, 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 positive results from the Phase 3 INDIGO trial of obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD). Obexelimab met the primary endpoint, demonstrating a highly statistically significant and clinically meaningful 56% reduction in the risk of IgG4-RD flare compared to placebo (Hazard Ratio 0.44, 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, which were reduction in investigator assessed IgG4-RD flare, the number of flares requiring rescue therapy, the proportion of patients achieving complete remission and the cumulative use of IgG4-RD rescue therapy. Rates of infections, including Grade 3, were lower in the obexelimab arm compared to placebo, and the incidence of injection site reactions was similar across both study arms. The Company expects that full data from the INDIGO trial will be presented at a future medical meeting.

“Given obexelimab’s significant clinical activity and the compelling safety and tolerability profile observed in the INDIGO trial, we believe obexelimab may have an important role as a first line therapy in the long-term management of IgG4-RD,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. “With its unique inhibitory mechanism, tolerability profile, at-home subcutaneous self-administration and potential to pause for vaccination or management of intercurrent illness, obexelimab has the potential to be a meaningful treatment option for patients. IgG4-RD represents a significant commercial opportunity for obexelimab and Zenas, and today’s data support obexelimab as a potential franchise molecule for rheumatic diseases.

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