Connect Biopharma Initiates Phase 2 Seabreeze STAT Asthma Study Evaluating Rademikibart for the Treatment of Acute Exacerbations in Asthma
- Demonstrated rapid improvement in lung function within 24 hours of administration
- Showed sustained improvements in lung function through 24 weeks in previous trials
- Potential to be first biologic indicated for acute asthma exacerbations
- FDA agreement received on final study protocol
- Strong results particularly in patients with high eosinophil counts (≥300 cells/μL)
- Results not expected until first half of 2026
- Still in early Phase 2 stage of development
- Will require larger Phase 3 trials for FDA approval
Insights
Connect Biopharma's Phase 2 trial for rademikibart shows promise for acute asthma exacerbations with unique rapid-action mechanism.
Connect Biopharma has initiated the Phase 2 Seabreeze STAT Asthma study after receiving FDA protocol approval, marking a significant advancement in their clinical pipeline. What makes this development particularly noteworthy is rademikibart's differentiated clinical profile demonstrating improvement in pulmonary function in less than 24 hours - a critical advantage for acute treatment scenarios that no other biologic has achieved.
The trial design involves approximately 160 participants globally who are experiencing acute asthma exacerbations, with a primary endpoint measuring treatment failure rate over 28 days following an exacerbation. This positions rademikibart to potentially become the first biologic indicated for acute asthma exacerbations, addressing a significant unmet need among the over 1 million asthma patients who visit emergency departments annually for acute exacerbations.
The scientific rationale is supported by previously published positive Phase 2 results in the American Journal of Respiratory and Critical Care Medicine showing rapid improvements in lung function within 24 hours plus sustained improvements through 24 weeks, with strongest responses in patients with baseline eosinophil counts ≥300 cells/μL. This suggests rademikibart specifically targets type 2 inflammation pathways effectively.
From a treatment paradigm perspective, biologics typically require weeks or months to demonstrate clinical benefit in respiratory conditions. Rademikibart's rapid onset of action would represent a paradigm shift in managing acute exacerbations, potentially reducing hospitalization rates, emergency department visits, and the cascading inflammatory damage that occurs during acute episodes.
With topline data expected in first half of 2026 and a parallel COPD study about to begin, Connect Biopharma is building a comprehensive respiratory inflammation platform that could significantly impact standard of care for acute respiratory exacerbations.
– 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 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,” said Mario Castro, M.D., MPH, Professor of Medicine and Chief, Division of Pulmonary, Critical Care and Sleep Medicine at University of Kansas Medical Center. “Rademikibart could become an important adjunct treatment option in hospitals for acute treatment of this vulnerable population.”
Seabreeze STAT Asthma is a Phase 2, randomized, double-blind, placebo-controlled study evaluating rademikibart as an adjunct to standard of care for acute exacerbations in adults and adolescent participants with asthma and type 2 inflammation. The study is expected to enroll approximately 160 participants globally who have an acute asthma exacerbation. Participants will receive either a single dose of rademikibart or placebo, administered subcutaneously. The primary endpoint is safety and efficacy of rademikibart as an adjunct to standard of care, as measured by the treatment failure rate over 28 days following an acute exacerbation. Secondary endpoints include rate and time to new asthma exacerbations, change-from-baseline in asthma symptom score and nocturnal awakenings, post-bronchodilator forced expiratory volume in one second (FEV1), and incidence of adverse events.
About Connect Biopharma and Rademikibart
Connect Biopharma is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and COPD. Headquartered in San Diego, California, the company is advancing rademikibart, a next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody. With an initial focus on acute exacerbations amongst the approximately 1 million asthma patients and 1.3 million COPD patients in the U.S. who visit an emergency room annually for an acute exacerbation—an area with significant unmet need—rademikibart has the potential to be initiated in the acute setting and then continued for chronic maintenance therapy in asthma and COPD. In a prior Phase 2 trial for chronic asthma, rademikibart demonstrated strong efficacy and safety data, with clinically meaningful reductions in exacerbations and rapid, statistically significant improvements in FEV1, observed within one week—and in most cases, within 24 hours via home spirometry.
For more information visit www.connectbiopharm.com.
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This press release discusses our product candidate, rademikibart, which is under clinical investigation and has not yet been approved for marketing by the U.S. Food and Drug Administration or by any other regulatory agency. No representation is made as to the safety or effectiveness of rademikibart for the uses for which it is being studied. The trademarks included herein are the property of the owners thereof and are used for reference purposes only.
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FAQ
What is the primary endpoint of CNTB's Seabreeze STAT Asthma Phase 2 trial?
How many participants will be enrolled in Connect Biopharma's Phase 2 Seabreeze STAT trial?
When will Connect Biopharma (CNTB) report topline data from the Seabreeze STAT study?
What makes rademikibart unique in treating asthma exacerbations?
What were the results of CNTB's previous Phase 2 trial with rademikibart?
