Connect Biopharma Announces New Phase 2 Study To Test Rademikibart For Acute Asthma Exacerbations

Connect Biopharma Holdings Limited, a clinical-stage biopharmaceutical company focused on transforming the treatment of asthma and chronic obstructive pulmonary disease (COPD), has announced the initiation of its Phase 2 Seabreeze STAT Asthma study. The study will evaluate the safety and efficacy of rademikibart as an adjunct to standard care for acute exacerbations in adults and adolescents with asthma and type 2 inflammation. The initiation follows the U.S. Food and Drug Administration’s (FDA) approval of the final study protocol.

This study comes after the publication of positive results from a 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). The data from that study demonstrated the potential of rademikibart to rapidly improve lung function within 24 hours of administration, with sustained improvements observed through 24 weeks. The greatest improvements were seen in patients with baseline eosinophil counts ≥300 cells/μL.

The Seabreeze STAT Asthma study is a Phase 2, randomized, double-blind, placebo-controlled trial designed to assess rademikibart as an adjunct to standard care for acute exacerbations in asthma patients with type 2 inflammation. The study will enroll approximately 160 participants globally who are experiencing an acute asthma exacerbation. Participants will receive either a single subcutaneous dose of rademikibart or a placebo. 

Barry Quart, Pharm.D., CEO and Director of Connect Biopharma, said in a statement, “We are pleased to initiate the Seabreeze STAT Asthma study as we execute on our rapid clinical development plan for rademikibart. 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.”

“I am excited to participate in the Seabreeze STAT Asthma study to evaluate the potential of rademikibart in patients experiencing an acute exacerbation. Over 1 million asthma patients visit the emergency department due to an acute exacerbation annually and I am encouraged by the data generated to date with rademikibart, highlighting rapid and sustained improvements in lung function in patients, particularly those with high eosinophil count. Rademikibart could become an important adjunct treatment option in hospitals for acute treatment of this vulnerable population,” commented Mario Castro, M.D., MPH, Professor of Medicine and Chief, Division of Pulmonary, Critical Care and Sleep Medicine at University of Kansas Medical Center. 

The primary endpoint will evaluate the safety and efficacy of rademikibart, as measured by the treatment failure rate within 28 days of an acute exacerbation. Secondary endpoints include the rate and time to new asthma exacerbations, changes in asthma symptom scores, nocturnal awakenings, post-bronchodilator forced expiratory volume in one second (FEV1), and the incidence of adverse events.