Core Viewpoint - Zenas BioPharma's Obexelimab has shown significant efficacy in treating relapsing multiple sclerosis (RMS) in the Phase 2 MoonStone trial, achieving a 95% reduction in new gadolinium-enhanced (GdE) T1 lesions compared to placebo, indicating a strong potential for this therapy in autoimmune diseases [1][3][9]. Group 1: Clinical Trial Results - The MoonStone trial demonstrated a statistically significant primary endpoint, with Obexelimab reducing the accumulation of new GdE T1 lesions by 95% (p=0.0009) compared to placebo [1][3]. - In the Obexelimab treatment group, near-complete suppression of new GdE T1 lesions was observed at 8 weeks, which continued to 12 weeks [3][12]. - The average number of new GdE T1 lesions in the Obexelimab group was 0.01, while the placebo group had 0.23, highlighting the treatment's effectiveness [9]. Group 2: Mechanism and Development - Obexelimab is a bifunctional antibody targeting CD19 and FcγRIIb, designed to inhibit B cell activity without causing B cell depletion, making it a promising candidate for various autoimmune diseases [3][4]. - The drug's unique mechanism, combined with its subcutaneous self-administration and tolerability, positions it as a potential option for addressing B cell-mediated pathologies in autoimmune diseases [16]. Group 3: Future Milestones and Collaborations - Zenas BioPharma is expected to report 24-week data from the MoonStone trial in Q1 2026, which will include additional secondary and exploratory endpoints [16]. - The company anticipates announcing the final results of the Phase 3 INDIGO trial for IgG4-related disease by the end of 2025 and the Phase 2 SunStone trial for systemic lupus erythematosus (SLE) in mid-2026 [16]. - Zenas has entered a collaboration agreement with Bristol Myers Squibb for Obexelimab's rights in several Asia-Pacific regions, enhancing its market reach [5][17].
股价暴涨33%！Zenas宣布CD19抗体Obexelimab临床II期大获成功 诺诚健华持股市值大增
美股IPO·2025-10-28 00:25