Mabwell Bioscience’s anti-ST2 monoclonal antibody (mAb) has led to a 40% reduction in annualised severe exacerbations in patients with chronic obstructive pulmonary disease (COPD)
In the randomised, double-blind, placebo-controlled Phase IIa trial (NCT06175351), the therapy – dubbed 9MW1911 – was found to be safe and well-tolerated across all dose groups. The overall incidence of adverse events (AEs) was 70% in the treatment groups, similar to the 85% incidence observed in the placebo group, meaning the trial met one of its primary endpoints.
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Pharmacokinetic (PK) data also suggested that drug exposure increased with escalating doses, with this being translated into efficacy, as data showed that the annualised rate of COPD exacerbation decreased in the higher doses.
At the recommended dose for the Phase IIb study, the annualised rate of moderate-to-severe COPD exacerbations was reduced by more than 30% compared to the placebo group.
In the full patient population, the annualised rate of severe exacerbations dropped by over 40% compared to the placebo group, and the proportion of patients experiencing severe exacerbations was significantly lower in the treatment group at 13.3% compared to 35% in the placebo group.
The trial enrolled 80 previously smoking patients with moderate-to-severe COPD who were randomised to receive intravenous (IV) infusions of either 9MW1911 100mg, 300mg, 600mg, 900mg, or placebo once every four weeks.
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By GlobalDataThe Shanghai-based company is already progressing the drug, with a Phase IIb trial ongoing and enrolling patients in China. Interim data from the Phase IIb trial is expected once data from 120 patients is available. The company also hopes to initiate a Phase III trial before the end of 2026 based on the Phase II outcomes.
The US Food and Drug Administration (FDA) has also accepted an application for the company to initiate a Phase IIa trial.
There are already two mAbs that have been approved by the FDA in COPD, notably Regeneron and Sanofi’s Dupixent (dupilumab) and GSK’s Nucala (mepolizumab).
GlobalData’s global patient-based forecast predicts Dupixent will dominate the COPD market, with sales expected to reach $6.57bn in COPD alone in 2033 while Nucala’s COPD sales are set to reach $3.45bn in the same year.
GlobalData is the parent company of Clinical Trials Arena.
While Sanofi and Regeneron have already secured a large market share with Dupixent, it is eyeing a greater share with its candidate itepekimab, which, after the company’s announced positive Phase III data, could become the first therapy specifically approved for former smokers. If approved, GlobalData predicts a global patient-based forecast of $2.17bn for in drug in COPD in 2033.
GlobalData predicts the COPD market across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) will grow from $11.6bn in 2023 to $30.2bn by 2033, with this growth expected to be largely fuelled by biologics.
