Connect Biopharma gains FDA alignment for Phase 2 trials of rademikibart in acute asthma/COPD

Connect Biopharma Holdings Ltd

FDA Type C meeting positive; agency aligned on parallel Phase 2 trials for rademikibart in acute exacerbations of asthma or COPD.
Two placebo-controlled trials each enrolling ~160 patients with eosinophils ≥300 cells/µL; single 600 mg SC dose over 28 days.
Initiation planned in Q2 2025; data expected in first half of 2026; cash runway into 2027.
CEO cites prior Phase 2 maintenance data showing rapid lung function improvement within 24 hours of 600 mg dose.
Unmet need highlighted: ~45% of patients on standard of care experience treatment failure within 28 days post-exacerbation.

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