Mabwell presented Phase Ib/IIa results for its anti-ST2 monoclonal antibody 9MW1911 in patients with moderate-to-severe COPD at ERS 2026.
The randomized, double-blind, placebo-controlled, multiple-dose dose-escalation trial enrolled 80 former smokers who received intravenous infusions every four weeks at 100 mg, 300 mg, 600 mg or 900 mg.
Pharmacokinetic data showed trough concentrations reached steady state around week 12 and exposure increased approximately dose-proportionally, and the company reports an overall favorable safety and tolerability profile.
In efficacy analyses versus placebo, the company reports reductions in annualized moderate-to-severe exacerbation rates of 24% and 81% in the 600 mg and 900 mg groups, respectively, and reductions in annualized severe exacerbations of 47% and 100% in those same dose groups.
The company claims these findings support further development; Phase IIb enrollment is complete, the FDA has cleared an IND for a U.S. Phase IIa study, and a Phase III trial is expected around late 2026.
