Core Insights - Zenas BioPharma has completed targeted enrollment for the Phase 3 INDIGO trial, the largest clinical trial for patients with IgG4-RD, and expects topline results by the end of 2025 [1][2] Company Overview - Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing and commercializing immunology-based therapies [9] - The company's lead product candidate, obexelimab, is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb to inhibit B cell activity without depleting them [9] INDIGO Trial Details - The Phase 3 INDIGO trial is a global, double-blind, placebo-controlled study involving approximately 190 patients across 100 sites in 20 countries [3] - Patients are randomized to receive either 250 mg of obexelimab or placebo weekly for 52 weeks, followed by an open-label extension period [3] - The primary efficacy endpoint is the time to first IgG4-RD flare, with secondary endpoints including annualized flare rate and complete remission rates [4] Obexelimab Clinical Background - Obexelimab has been evaluated in five completed clinical trials with a total of 198 patients, demonstrating good tolerance and clinical activity [5] - The drug is currently being tested in multiple Phase 2 and Phase 3 trials for various autoimmune diseases, including IgG4-RD, Multiple Sclerosis, and Systemic Lupus Erythematosus [5] IgG4-RD Overview - IgG4-RD is a chronic fibro-inflammatory disease affecting multiple organ systems, with an estimated 20,000 diagnosed patients in the U.S. [6] - There are currently no approved therapies for IgG4-RD, and the standard treatment involves glucocorticoids, which can lead to complications and relapses [7] Therapeutic Landscape - B cell-targeted therapies are suggested to provide benefits for IgG4-RD, although existing agents like rituximab are not approved for this indication and carry risks of infections [8]
Zenas BioPharma Completes Targeted Enrollment of the Phase 3 INDIGO Trial of Obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD)