Zenas BioPharma Reports 95% Reduction in MS Lesions

By Ahmed Jameison • Monday, October 27 10:28 • Permanent Link

Zenas Biopharma, Inc. has announced positive results from the Phase 2 Moonstone trial of Obexelimab in relapsing multiple sclerosis (RMS). The trial demonstrated a highly statistically significant 95% relative reduction in the cumulative number of new gadolinium (GD)-enhancing (GDE) T1 hyperintense lesions over week 8 and week 12 compared with placebo, with a p-value of 0.0009.

The adjusted mean number of new GDE T1 hyperintense lesions per scan in the Obexelimab group was 0.01 compared to 0.23 with placebo, showcasing near-complete suppression of these markers of active inflammation. Over weeks 8 and 12 of treatment, Obexelimab significantly reduced the cumulative number of new and/or enlarging T2 weighted hyperintense lesions compared to placebo, which represent the amount of disease burden or chronic lesion load.

Zenas also expects to report topline results from the Obexelimab Phase 3 Indigo trial in IgG4-RD around year-end 2025 and topline results from the Phase 2 Sunstone trial in systemic lupus erythematosus (SLE) in mid-2026. Additionally, Orelabrutinib, a potentially best-in-class, highly-selective central nervous system (CNS)-penetrant, oral, small molecule Bruton’s tyrosine kinase (BTK) inhibitor, which Zenas recently in-licensed from Innocare Pharma Limited, is now being studied in a global Phase 3 clinical trial in patients with primary progressive multiple sclerosis (PPMS).

The company is also set to initiate a global Phase 3 trial of Orelabrutinib in patients with secondary progressive multiple sclerosis (SPMS) in the first quarter of 2026.

Multiple sclerosis (MS) is a chronic, autoimmune-mediated disorder of the central nervous system (CNS) that affects approximately 2.9 million people worldwide. Zenas is committed to becoming a leader in the development and commercialization of transformative therapies for patients living with autoimmune diseases, with a focus on addressing the pathogenic role of B cells in chronic autoimmune diseases. The market has reacted to these announcements by moving the company's shares -4.46% to a price of $23.895. If you want to know more, read the company's complete 8-K report here.

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