On December 24, Maiwei Bio announced that its independently developed anti-ST2 monoclonal antibody innovative drug (development code: 9MW1911) has officially received approval from the US FDA for clinical trials, which can be used to conduct phase 2a clinical studies for moderate to severe chronic obstructive pulmonary disease (COPD) .

9MW1911 binds to the ST2 receptor with high affinity, thereby blocking the IL33/ST2 signaling pathway. This drug has completed a Phase 2a clinical trial (N=80) in China for patients with moderate to severe COPD, and the results showed:

Compared with placebo (N=20), the study was safe and well-tolerated in all dose groups, with an overall adverse event rate similar to that in the placebo group (70% vs 85%). All subjects were immunogenic and no new safety risk signals were identified.

Pharmacokinetic results suggest that drug exposure increases with increasing dose, and the exposure-response model can preliminarily establish a dose-response relationship, providing a basis for subsequent dose selection.

Efficacy data showed that the annualized incidence of COPD exacerbations in the experimental group decreased with increasing dose; at the recommended dose in the phase 2b study (RP2D, N=30), the annualized incidence of moderate to severe COPD exacerbations was reduced by more than 30% compared to the placebo group, the annualized incidence of severe exacerbations was reduced by more than 40% compared to the placebo group, and the proportion of patients experiencing severe exacerbations was significantly lower than that in the placebo group (13.3% vs 35%).

The Phase 2b clinical trial, which aims to assess the efficacy and safety of the drug in a larger sample of COPD patients, achieved its first dose in July 2025. Currently, subjects are actively being enrolled. The plan is to conduct an interim analysis after obtaining data from the last visit of at least 120 subjects. Based on the evaluation of the Phase 2 clinical trial results, it is hoped that a Phase 3 clinical trial will be initiated by the end of 2026 to observe safety, efficacy, and immunogenicity.

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