Zenas BioPharma, Inc.(US:ZBIO) Globenewswire·2025-10-27 11:05Core Insights - Zenas BioPharma announced positive results from the Phase 2 MoonStone trial of obexelimab in Relapsing Multiple Sclerosis (RMS), achieving a 95% relative reduction in new gadolinium-enhancing T1 lesions compared to placebo [1][2][3] Company Overview - Zenas BioPharma is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases [12] - The company is advancing two late-stage product candidates: obexelimab and orelabrutinib, with obexelimab being the lead candidate [12] Clinical Trial Results - The MoonStone trial enrolled 116 patients and demonstrated a near-complete suppression of new GdE T1 hyperintense lesions by 8 weeks, sustained through week 12 [3][9] - The adjusted mean number of new GdE T1 lesions per scan in the obexelimab group was 0.01 compared to 0.23 in the placebo group [3] - Obexelimab also significantly reduced the cumulative number of new and/or enlarging T2 weighted hyperintense lesions, indicating a reduction in disease burden [3] Future Developments - Zenas plans to report 24-week data from the MoonStone trial in Q1 2026, which will include additional secondary and exploratory endpoints [4] - The company expects to report topline results from the Phase 3 INDIGO trial in IgG4-RD by the end of 2025 and from the Phase 2 SunStone trial in Systemic Lupus Erythematosus by mid-2026 [4] Mechanism of Action - Obexelimab is a bifunctional monoclonal antibody designed to inhibit B cell activity without depleting them, targeting both CD19 and FcγRIIb [10][12] - This unique mechanism may effectively address the pathogenic role of B cells in chronic autoimmune diseases [10][12] Disease Context - Multiple Sclerosis (MS) is a chronic autoimmune disorder affecting approximately 2.9 million people globally, with RMS being the most common subtype [5][8] - Early intervention with effective therapies is crucial to manage the disease and prevent disability progression [7][8]