Mabwell Receives the US FDA IND Clearance to Initiate P-IIa Trial of 9MW1911 in COPD
Shots:
- The US FDA has granted IND clearance to initiate a P-IIa trial of 9MW1911 for the treatment of patients with mod. to sev. chronic obstructive pulmonary disease (COPD)
- In the China P-IIa trial (n=80) vs PBO, 9MW1911 showed dose-proportional exposure & dose-dependent efficacy, with the RP2D (n=30) reducing mod. to sev. COPD exacerbations by over 30%, & severe exacerbations by over 40%; 13.3% vs 35% pts experienced severe exacerbations
- The P-IIb study of 9MW1911 in a broader COPD population dosed its first patient in Jul 2025, with an interim analysis planned after ≥120 pts. The company also aims to initiate a P-III trial by the end of 2026
Ref: PRnewswire | Image: Mabwell | Press Release
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