Connect Biopharma Initiates Phase 2 Seabreeze STAT Study To Test Rademikibart For Treating Acute COPD Exacerbations

Connect Biopharma Holdings Limited, a clinical-stage biopharmaceutical company focused on improving the treatment of asthma and chronic obstructive pulmonary disease (COPD), has announced the initiation of its Phase 2 Seabreeze STAT COPD study (NCT06940154). This milestone comes after receiving written agreement on the final study protocol from the U.S. Food and Drug Administration (FDA). The study will assess the safety and efficacy of rademikibart as an adjunct to standard care for acute exacerbations in patients with COPD and type 2 inflammation.

The launch of the Seabreeze STAT COPD study follows a post-hoc analysis of COPD-like patients from the company’s previously completed global Phase 2b Asthma study. The analysis revealed promising data suggesting that rademikibart may improve outcomes for COPD patients, particularly those with elevated baseline eosinophil counts. Connect Biopharma plans to present these findings at the upcoming American Thoracic Society (ATS) 2025 International Conference, which will be held from May 18-21, 2025, in San Francisco.

Barry Quart, Pharm.D., CEO and Director of Connect Biopharma, said in a statement, “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. 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.”

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, mentioned, “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. 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.”

The Seabreeze STAT COPD study is a Phase 2, randomized, double-blind, placebo-controlled trial. It will evaluate rademikibart as an adjunct to standard care in treating acute exacerbations in participants with COPD and type 2 inflammation. The study aims to enroll approximately 160 participants globally who have an acute COPD exacerbation and an eosinophil count of ≥300 cells/μL. Participants will receive either a single subcutaneous dose of rademikibart or a placebo.

The primary endpoint of the study is to assess the safety and efficacy of rademikibart, with a focus on the treatment failure rate within 28 days following an acute exacerbation. Secondary endpoints will include the rate and time to new moderate and severe COPD exacerbations, changes in clinical respiratory symptoms of COPD from baseline, post-bronchodilator forced expiratory volume in one second (FEV1), and the incidence of adverse events.