Connect Biopharma has initiated its Phase 2 Seabreeze STAT Asthma study to evaluate rademikibart’s safety and efficacy as an add-on treatment for acute asthma exacerbations in adults and adolescents with type 2 inflammation. The U.S. Food and Drug Administration (FDA) approved the final study protocol, and topline data is expected in the first half of 2026. A similarly designed Phase 2 study for COPD is also on the horizon.
This study is important because it addresses a significant unmet need in acute asthma care. Over one million asthma patients in the US annually visit emergency departments due to exacerbations. Rademikibart’s potential to rapidly improve lung function, sometimes within 24 hours, offers a promising new approach to managing these events and preventing subsequent exacerbations during the vulnerable post-exacerbation period. This could translate to a significant reduction in hospitalizations and improved patient outcomes.
The Seabreeze STAT Asthma study is a randomized, double-blind, placebo-controlled trial involving approximately 160 participants globally. Participants experiencing an acute exacerbation will receive a single dose of rademikibart or a placebo. The primary endpoint is the treatment failure rate over 28 days. Secondary endpoints include the rate and time to new exacerbations, changes in asthma symptom scores, lung function measurements, and adverse events. This follows positive Phase 2 trial results published in the American Journal of Respiratory and Critical Care Medicine, which showed rapid and sustained lung function improvement with rademikibart, especially in patients with high eosinophil counts.
Positive results from the Seabreeze STAT Asthma study could position rademikibart as the first biologic specifically indicated for acute asthma exacerbations. This would not only represent a significant advancement in asthma care but could also establish rademikibart as a key player in both acute and chronic asthma management, potentially leading to improved long-term outcomes for patients and a significant market opportunity for Connect Biopharma. The upcoming COPD study further expands the potential application of rademikibart to another large patient population with significant unmet needs.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
