Mabwell's Anti-ST2 Antibody 9MW1911 Shows Over 40% Reduction in Severe COPD Exacerbations in Phase IIa Trial
核心洞察
Mabwell (搜索)'s Phase IIa trial of 9MW1911, an anti-ST2 (搜索) monoclonal antibody, demonstrated over 40% reduction in severe COPD (搜索) exacerbations compared to placebo in 80 patients with moderate-to-severe disease.
The drug showed dose-dependent efficacy with over 30% reduction in moderate-to-severe exacerbations at the recommended Phase IIb dose, while maintaining good safety profile with similar adverse event rates to placebo.
Phase IIb study is progressing with first patient dosed in July 2025, interim analysis planned after 120 patients, and Phase III trial expected by end of 2026.
Mabwell (搜索) (688062.SH) has announced positive results from its Phase IIa clinical study of 9MW1911, an innovative anti-ST2 (搜索) monoclonal antibody for treating moderate-to-severe chronic obstructive pulmonary disease (搜索) (COPD (搜索)). The randomized, double-blind, placebo-controlled trial demonstrated significant reductions in COPD exacerbations, with severe exacerbations reduced by over 40% at the recommended Phase IIb dose.
Phase IIa Trial Design and Results
The completed Phase IIa study (9MW1911-C03) was a multiple-dose, dose-escalation trial that enrolled 80 patients with moderate-to-severe COPD (搜索) who were previously smokers. Patients were randomized to receive intravenous infusions of 9MW1911 at doses of 100mg, 300mg, 600mg, or 900mg, or placebo, administered once every four weeks.
The study primarily evaluated safety, tolerability, and pharmacokinetic characteristics of 9MW1911, while also conducting preliminary assessments of efficacy and immunogenicity. Baseline characteristics were generally balanced across all groups, with the majority of subjects having a baseline blood eosinophil count of <300/μL.
Safety and Tolerability Profile
9MW1911 demonstrated good safety and tolerability across all dose groups compared to placebo. The overall incidence of adverse events was similar between treatment groups and placebo (70% vs. 85%). Importantly, immunogenicity was negative in all subjects, and no new safety risk signals were identified during the study.
Pharmacokinetic results showed that drug exposure increased with escalating doses, allowing researchers to establish a preliminary exposure-response model to define the dose-effect relationship for subsequent dose selection.
Efficacy Outcomes
The efficacy data revealed dose-dependent reductions in COPD (搜索) exacerbation rates across treatment arms. At the recommended dose for the Phase IIb study (N=30), the annualized rate of moderate-to-severe COPD exacerbations was reduced by over 30% compared to the placebo group.
More notably, the annualized rate of severe exacerbations was reduced by over 40% compared to placebo. The proportion of patients experiencing severe exacerbations was significantly lower in the treatment group than in the placebo group (13.3% vs. 35%).
Development Timeline and Regulatory Progress
9MW1911 is an innovative anti-ST2 (搜索) antibody developed using Mabwell (搜索)'s high-efficiency B-cell screening platform. The company is currently advancing the drug through a Phase IIb study in a larger COPD (搜索) population, with first patient dosing completed in July 2025.
An interim analysis is planned after data from at least 120 patients are collected. Based on the Phase II outcomes, Mabwell (搜索) expects to begin a Phase III trial by the end of 2026. The Phase IIa trial application has recently been accepted by the U.S. FDA, marking progress in the drug's regulatory pathway.
Clinical Significance
The results represent a potential advancement in COPD (搜索) treatment, particularly for patients experiencing frequent exacerbations. The dose-dependent efficacy profile and favorable safety data support continued development of 9MW1911 as a novel therapeutic approach targeting the ST2 (搜索) pathway in COPD management.