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Investing.com -- Zenas BioPharma (NASDAQ:ZBIO) stock surged 80% on Monday after the company announced positive results from its Phase 2 MoonStone trial of obexelimab in Relapsing Multiple Sclerosis (RMS).
The clinical-stage biopharmaceutical company reported that obexelimab met its primary endpoint, demonstrating a 95% relative reduction in new gadolinium-enhancing T1 lesions compared to placebo. The highly statistically significant results (p=0.0009) showed near-complete suppression of these inflammatory markers by week 8 of treatment, which was sustained through week 12.
The adjusted mean number of new lesions per scan in the obexelimab group was 0.01 compared to 0.23 with placebo. Additionally, the drug significantly reduced the cumulative number of new and/or enlarging T2 weighted hyperintense lesions compared to placebo, which represent disease burden or chronic lesion load.
"These profound MoonStone trial results, including the near elimination of new GdE T1 lesions, provide strong evidence of the deep and sustained inhibitory mechanism of obexelimab and further validate the potential for obexelimab to become a meaningful therapy across multiple autoimmune diseases," said Lonnie Moulder, Founder and Chief Executive Officer of Zenas.
The company reported that the safety profile was consistent with prior trials, with most adverse events being mild injection site reactions, along with some cases of infections and hypersensitivity.
Zenas plans to report 24-week data from the MoonStone trial in the first quarter of 2026. The company is also expecting topline results from the obexelimab Phase 3 INDIGO trial in IgG4-RD around year-end 2025 and from the Phase 2 SunStone trial in Systemic Lupus Erythematosus by mid-2026.
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