Annualized Severe COPD Exacerbation Rate Reduced by Over 40%: Mabwell Announces Phase IIa Results for Innovative Anti-ST2 Antibody 9MW1911

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[{"type":"list","items":[{"val":[{"type":"text","content":"All dose groups demonstrated good safety and tolerability versus placebo, with similar adverse event (AE) incidence (70% vs. 85%).","length":130,"tagName":"p"}]},{"val":[{"type":"text","content":"At the recommended Phase IIb dose (RP2D), the annualized rate of moderate-to-severe exacerbations decreased by over 30%, and severe exacerbations decreased by over 40%.","length":168,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":298,"olType":false},{"type":"text","content":"SHANGHAI, Dec. 1, 2025 /PRNewswire/ -- Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced the completion of its Phase IIa clinical study for 9MW1911, a self-developed anti-ST2 monoclonal antibody, in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).","length":350,"tagName":"p"},{"type":"text","content":"The completed Phase IIa clinical study (9MW1911-C03) was a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation trial. The study primarily evaluated the safety, tolerability, and pharmacokinetic characteristics of 9MW1911 in previously smoking patients with moderate-to-severe COPD, and included preliminary assessments of efficacy and immunogenicity. A total of 80 patients were enrolled and randomized to receive intravenous infusions of 9MW1911 (100mg, 300mg, 600mg, 900mg) or placebo once every four weeks.","length":534,"tagName":"p"},{"type":"text","content":"The results indicated that the baseline characteristics were generally balanced across all groups, and the majority of subjects had a baseline blood eosinophil count of <300/μL. Compared to placebo (N=20), 9MW1911 was safe and well-tolerated across all dose groups, with the overall incidence of adverse events (AEs) being similar to the placebo group (70% vs. 85%). Immunogenicity was negative in all subjects, and no new safety risk signals were identified. Pharmacokinetic results suggested that drug exposure increased with escalating doses. An exposure-response model can be preliminary established to define the dose-effect relationship, providing a basis for subsequent dose selection. Efficacy data showed that the annualized rate of COPD exacerbation demonstrated a dose-dependent decrease in the treatment arms. At the recommended dose for th...

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