Zenas BioPharma, Inc. has announced promising results from its Phase 2 MoonStone trial of obexelimab, specifically for patients with Relapsing Multiple Sclerosis (RMS). The trial revealed a statistically significant 95% relative reduction in new gadolinium-enhancing T1 hyperintense lesions at weeks 8 and 12 compared to placebo (p=0.0009), marking a substantial advancement in therapeutic options for this chronic condition.
The results underscore obexelimab’s potential as a transformative treatment for RMS and other autoimmune diseases, as highlighted by CEO Lonnie Moulder. The near-complete suppression of inflammatory lesions indicates a robust inhibitory mechanism, which could extend to other conditions currently under investigation, such as Immunoglobulin G4-Related Disease and Systemic Lupus Erythematosus.
With the safety profile aligning with previous trials, Zenas is poised to report further data, including 24-week outcomes in early 2026. The implications for regulatory and clinical pathways are significant, as the data may inform future strategies for addressing disability progression in MS. Additionally, Zenas is advancing its pipeline with orelabrutinib, a BTK inhibitor, further enhancing its position in the autoimmune disease landscape.
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