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Connect Biopharma reports rademikibart reduced COPD treatment failure by 81% in Phase 2 Seabreeze study
CNTBConnect Biopharma Holdings Ltd
Connect Biopharma Holdings Limited announced positive topline results from its global Phase 2 Seabreeze STAT COPD study evaluating rademikibart, an anti-IL-4Rα antibody, as an add-on treatment for acute exacerbations in adults with COPD and type 2 inflammation. The study enrolled 159 participants randomized 1:1 to receive a single subcutaneous dose of rademikibart or placebo. Rademikibart significantly reduced the rate of treatment failure by 81% (p=0.0122) and new moderate-to-severe exacerbations by 85% (p=0.030) through Week 4 compared to placebo. The drug also eliminated emergency department visits and hospital admissions for new exacerbations by 100% (p=0.0137), reduced rescue inhaler use, and improved respiratory symptoms. A clinically meaningful 70 mL improvement in FEV1 was observed at Week 4, though it did not reach statistical significance (p=0.1607). The treatment was well-tolerated with no new safety signals. Connect plans to engage the FDA regarding a Phase 3 program. Connect Biopharma Holdings Limited is a clinical-stage biopharmaceutical company focused on developing therapies for inflammatory respiratory diseases.