Connect Biopharma completes Phase 2 Seabreeze STAT Asthma study enrollment
Connect Biopharma Holdings Limited has completed enrollment in its Phase 2 Seabreeze STAT Asthma study, evaluating rademikibart for acute exacerbations in asthma. The study enrolled 160 participants globally, with topline data expected in early September 2026. The company also anticipates completing enrollment in the Seabreeze STAT COPD study this month and plans to meet with the FDA later this year to align on a Phase 3 program.
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Connect Biopharma Holdings Limited has completed enrollment in its Phase 2 Seabreeze STAT Asthma study, evaluating the safety and efficacy of rademikibart for acute exacerbations in asthma. The study enrolled 160 participants globally who experienced an acute asthma exacerbation with an eosinophil count of ≥300 cells/μL. Participants received either a single dose of rademikibart or placebo, administered subcutaneously, as an adjunct to standard of care. The primary endpoint is the treatment failure rate over 28 days following an acute exacerbation, with key secondary endpoints including post-bronchodilator forced expiratory volume in one second (FEV1) at Week 1.
Barry Quart, Pharm.D., CEO and Director of Connect Biopharma, stated that the completion marks a significant step in delivering the first biologic for acute asthma exacerbations. The company expects to report topline data from the Seabreeze STAT Asthma study in early September 2026. Following this, data from the Phase 2 Seabreeze STAT COPD study is anticipated soon after. Connect Biopharma plans to meet with the U.S. Food and Drug Administration (FDA) later this year to align on a Phase 3 program.
The Seabreeze STAT COPD study is a randomized, double-blind, placebo-controlled trial also evaluating rademikibart for acute exacerbations in participants with COPD and type 2 inflammation. Enrollment for this study is anticipated to complete this month, targeting 160 participants globally. The primary and key secondary endpoints mirror those of the asthma study, focusing on treatment failure rate and post-bronchodilator FEV1 at Week 1.
Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα), designed to block the functions of IL-4 and IL-13. Connect Biopharma holds an exclusive license with Simcere Pharmaceutical Co., Ltd. for rademikibart in Greater China, eligible for milestone payments of approximately $110 million and royalties on net sales. The company maintains a strong balance sheet with a cash runway into the second half of 2027.
Key Study Details
| Feature | Seabreeze STAT Asthma Study | Seabreeze STAT COPD Study |
|---|---|---|
| Phase | Phase 2 | Phase 2 |
| Participants | 160 | 160 (anticipated) |
| Condition | Asthma with type 2 inflammation | COPD with type 2 inflammation |
| Primary Endpoint | Treatment failure rate over 28 days | Treatment failure rate over 28 days |
| Key Secondary Endpoint | Post-BD FEV1 at Week 1 | Post-BD FEV1 at Week 1 |
What criteria will the FDA likely prioritize during the upcoming meeting to approve a Phase 3 program for an acute exacerbation indication?
How will the upcoming COPD data influence the overall commercial strategy and market potential for rademikibart?
What are the contingency plans for capital allocation if the Phase 2 data does not support a Phase 3 launch given the cash runway into 2027?
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