Mabwell Reports Clinical Progress for COPD Candidate 9MW1911

The randomized, double-blind study evaluated the safety and efficacy of 9MW1911 in former smokers with moderate-to-severe COPD. Patients received intravenous infusions ranging from 100 mg to 900 mg every four weeks. Researchers observed that the drug reached steady-state concentrations by week 12, with exposure levels increasing proportionally to the dose administered. Safety data indicated the treatment was generally well-tolerated.

Efficacy findings highlighted a notable dose-response relationship. The 900 mg cohort achieved a 100% reduction in the annualized rate of severe COPD exacerbations compared to the placebo group, while the 600 mg group showed a 47% reduction. For moderate-to-severe exacerbations, the treatment groups reported reductions of 81% and 24%, respectively. Following these results, Mabwell has finalized enrollment for a Phase IIb study and anticipates starting Phase III trials by the end of 2026. The drug has also received U.S. FDA clearance for a Phase IIa trial.