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Mabwell Bioscience’s anti-ST2 monoclonal antibody, 9MW1911, demonstrated safety and tolerability in a Phase IIa randomized, double-blind, placebo-controlled trial (NCT06175351) involving 80 former smokers with moderate-to-severe COPD. Adverse event incidence was 70% in treated patients versus 85% in placebo, meeting a primary safety endpoint. Pharmacokinetic data showed dose-dependent exposure, correlating with reduced annualized COPD exacerbation rates. At the recommended Phase IIb dose, moderate-to-severe exacerbations fell by over 30%, while severe exacerbations decreased by more than 40% compared to placebo, with 13.3% of patients affected versus 35%. Mabwell is conducting a Phase IIb trial in China and plans a Phase III study by late 2026, with a US Phase IIa trial accepted by the FDA. With Dupixent and Nucala already approved, the COPD biologics market is projected to reach $30.2bn in the 7 major markets by 2033.
01-12-2025