Zenas BioPharma announced positive results from the Phase 3 INDIGO trial of obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD).
Obexelimab demonstrated a clinically meaningful 56% reduction in the risk of IgG4-RD flare and showed activity on all four key secondary endpoints.
The company expects to submit a Biologics License Application (BLA) to the FDA in the second quarter of 2026.
Positive Trial Results
Obexelimab achieved a 56% reduction in the risk of IgG4-RD flare and met all four key secondary endpoints.
Commercial Opportunity
Obexelimab has the potential to become a significant treatment option for patients with IgG4-RD, presenting a commercial opportunity for Zenas BioPharma.
Support from Experts
Experts commend the unique inhibitory mechanism and self-administration features of obexelimab, suggesting it as an important therapy for IgG4-RD.
Validation of Mechanism
The Phase 3 INDIGO results validate obexelimab's mechanism of action and dosing in addressing unmet medical needs in autoimmune diseases.
- The positive results from the Phase 3 INDIGO trial position obexelimab as a promising treatment option for patients with IgG4-RD.
- Obexelimab's unique inhibitory mechanism and favorable safety profile could lead to it becoming a first-line therapy for the long-term management of IgG4-RD.
The Phase 3 INDIGO trial results underscore the potential of obexelimab to address the needs of patients with IgG4-RD, marking a significant milestone for Zenas BioPharma and paving the way for future regulatory submissions.