Zenas BioPharma, Inc. (ZBIO), a clinical-stage biopharmaceutical company, reported on Thursday its submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Obexelimab in treating patients with Immunoglobulin G4-Related disease or IgG4-RD. Obexelimab is an investigational, bifunctional monoclonal antibody designed to inhibit B-cell functions by binding to CD19, a protein found on the surface of B cells and FcgRIIb, a receptor found on B cells and other immune cells. Immunoglobulin G4-Related disease is a chronic fibro-inflammatory disease which affects multiple organ systems. If untreated, it often results in irreversible tissue damage and organ failure.
The company has submitted BLA based on positive results of Phase 3 INDIGO registrational trial of Obexelimab in IgG4-RD.
In the Phase 3 INDIGO trial, Obexelimab met the primary endpoint and all key secondary endpoints.The results demonstrated by Obexelimab include 56% reduction in the risk of IgG4-RD flare compared to placebo during the 52-week randomized placebo-controlled period.
The firm continues to evaluate patients in a three-year open label extension period for IgG4-RD. Data from the INDIGO trial will be presented at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress in London, UK, on June 4, 2026.
In addition, Obexelimab is also being evaluated for Systemic Lupus Erythematosus and the firm noted that enrollment for it in the randomized Phase 2 trial is complete and it expects to release results in the fourth quarter of 2026.
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