Connect Biopharma Initiates Phase 2 Seabreeze STAT COPD Study Evaluating Rademikibart for the Treatment of Acute Exacerbations in COPD

– Expect to report topline data from the Seabreeze STAT COPD study in 1H 2026 –

SAN DIEGO, May 14, 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 COPD study (NCT06940154) 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 participants with COPD and type 2 inflammation.

“The initiation of our second Phase 2 study in patients with inflammatory lung disease highlights our commitment to swiftly advancing the development of rademikibart for asthma and COPD,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “In the current treatment landscape for patients experiencing an acute exacerbation with asthma or COPD, there are no approved biologics that can rapidly improve lung function and prevent further exacerbations over the short- and long-term. Based on our recently published Phase 2 data we believe rademikibart holds the potential to be the first biologic to deliver on this promise.”

The initiation of the Seabreeze STAT COPD study follows a post-hoc analysis in COPD-like patients from the Company’s previously completed global Phase 2b Asthma study. Data from the post-hoc analysis highlights the potential of rademikibart to improve outcomes for patients with COPD, with greatest improvements being observed in patients with elevated baseline eosinophil counts. Connect will present these data at the upcoming American Thoracic Society (ATS) 2025 International Conference, taking place May 18-21, 2025, in San Francisco.

“The arrival of biologics greatly advanced how we manage symptoms in COPD and asthma, but there remains a major unmet need for a fast, effective treatment immediately following acute exacerbations,” said Surya Bhatt, MD, Professor of Medicine in the Division of Pulmonary, Allergy and Critical Care Medicine at the University of Alabama at Birmingham School of Medicine. “Currently, 1.3 million patients visit the emergency department each year for a COPD flare-up and approximately 50% experience treatment failure within four weeks of an exacerbation. I am excited to take part in the Seabreeze STAT COPD study and evaluate whether rademikibart can deliver rapid, lasting relief for these patients.”