other material
confidence high
sentiment positive
materiality 0.85
Connect Biopharma's rademikibart cuts COPD treatment failure 81% in Phase 2; plans FDA Phase 3 talks
Connect Biopharma Holdings Ltd
- Phase 2 Seabreeze STAT (CBP-201-207) enrolled 159 COPD patients with eosinophils >=300 cells/uL; randomized 1:1 to single subcutaneous rademikibart or placebo plus standard of care.
- Treatment failure rate fell 81% through Week 4 vs placebo (p=0.0122); new moderate-to-severe COPD exacerbations fell 85% (p=0.030).
- ED visits and hospital admissions for new exacerbations reduced 100% (p=0.0137); rescue inhaler use cut from Week 2-7 with symptom improvement at Week 2 (p=0.0197).
- FEV1 improved 70 mL at Week 4 vs placebo but missed significance (p=0.1607); rademikibart well tolerated with lower adverse and serious adverse event rates than placebo.
- CEO Barry Quart cited 2025 claims data showing ~$6B in 30-day COPD ED return-visit costs; Connect plans to engage FDA on a Phase 3 registrational program.