迈威生物抗ST2单抗创新药9MW1911公布IIa期临床研究结果

Core Viewpoint - Maiwei Biotech announced the completion of Phase IIa clinical study for its self-developed anti-ST2 monoclonal antibody (code: 9MW1911) in patients with moderate to severe chronic obstructive pulmonary disease (COPD), demonstrating promising safety and efficacy results compared to placebo [1] Group 1: Clinical Study Results - The Phase IIa study showed that all dosage groups of 9MW1911 exhibited good safety and tolerability, with an overall adverse event rate similar to the placebo group (70% vs 85%) [1] - The annualized rate of acute exacerbations for moderate COPD patients was reduced by over 30% compared to the placebo group at the recommended Phase IIb dose (RP2D) [1] - The annualized rate of severe acute exacerbations was reduced by over 40% compared to the placebo group [1] Group 2: Drug Development Background - 9MW1911 is an innovative monoclonal antibody developed by Maiwei Biotech based on a high-efficiency B lymphocyte screening platform [1] - The drug is classified as a Class 1 therapeutic biological product and binds with high affinity to the ST2 receptor, thereby blocking the IL33/ST2 signaling pathway [1]