
Core Viewpoint - Connect Biopharma is advancing the development of rademikibart, a potential treatment for acute exacerbations in patients with COPD and asthma, with the initiation of the Phase 2 Seabreeze STAT COPD study expected to report topline data in the first half of 2026 [1][2] Company Overview - Connect Biopharma is a clinical-stage biopharmaceutical company focused on transforming care for asthma and COPD, headquartered in San Diego, California [4] - The company is developing rademikibart, a next-generation anti-interleukin-4-receptor alpha (IL-4Rα) antibody, targeting the significant unmet need in acute exacerbations among asthma and COPD patients [4] Study Details - The Seabreeze STAT COPD study is a Phase 2, randomized, double-blind, placebo-controlled trial evaluating rademikibart as an adjunct to standard care for acute exacerbations in COPD patients with type 2 inflammation [3] - Approximately 160 participants will be enrolled globally, characterized by an eosinophil count of ≥300 cells/μL, receiving either rademikibart or placebo [3] - The primary endpoint is the safety and efficacy of rademikibart, measured by the treatment failure rate over 28 days following an acute exacerbation [3] Market Need - There is a major unmet need for fast and effective treatments for acute exacerbations in COPD and asthma, with 1.3 million patients visiting emergency departments annually for COPD flare-ups [3] - Approximately 50% of these patients experience treatment failure within four weeks of an exacerbation, highlighting the necessity for new therapeutic options [3] Clinical Data - Previous Phase 2 data indicated that rademikibart has the potential to improve outcomes for COPD patients, particularly those with elevated eosinophil counts [2] - In prior trials, rademikibart demonstrated strong efficacy and safety, with significant reductions in exacerbations and rapid improvements in forced expiratory volume (FEV1) observed within one week [4]