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Connect Biopharma Initiates Phase 2 Seabreeze STAT Asthma Study Evaluating Rademikibart for the Treatment of Acute Exacerbations in Asthma
– Expect to report topline data from the Seabreeze STAT Asthma study in 1H 2026 – – On track to initiate similarly-designed Phase 2 study in patients with
About this update from Connect Biopharma Holdings Limited
[{"type":"text","content":"– Expect to report topline data from the Seabreeze STAT Asthma study in 1H 2026 – – On track to initiate similarly-designed Phase 2 study in patients with COPD imminently – SAN DIEGO, May 13, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect or the Company), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care of asthma and chronic obstructive pulmonary disease (COPD), today announced the initiation of its Phase 2 Seabreeze STAT Asthma study (NCT06940141) following written agreement on the final study protocol from the U.S. Food and Drug Administration. The study will evaluate the safety and efficacy of rademikibart as an adjunct to standard of care for acute exacerbations in adults and adolescent participants with asthma and type 2 inflammation. “We are pleased to initiate the Seabreeze STAT Asthma study as we execute on our rapid clinical development plan for rademikibart,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “Rademikibart has demonstrated a differentiated clinical profile, delivering robust improvements in pulmonary function in less than 24 hours, which is essential for treating patients in the acute setting, and which no other biologic has shown to date. With the initiation of this study, we have the potential to establish rademikibart as the first and only biologic indicated for patients experiencing an acute exacerbation of asthma and to prevent further exacerbations during the most vulnerable period in the month following an exacerbation. We are excited to begin enrolling patients in the study and expect to report topline data in the first half of 2026.” The initiation of the Seabreeze STAT Asthma study follows the publication of positive results from the global Phase 2 trial of rademikibart in patients with moderate-to-severe uncontrolled asthma in the American Journal of Respiratory and Critical Care Medicine (AJRCCM). Data from the study highlights the potential of rademikibart to rapidly improve lung function within 24 hours of administration as well as providing sustained improvements in lung function through 24 weeks, with greatest improvements being observed in patients with baseline eosinophil counts ≥300 cells/μL. “I am excited to participate in the Seabreeze STAT Asthma study to evaluate the p...