Announcement • Apr 25
Connect Biopharma Holdings Limited Continues Enrollment in Phase 2 Seabreeze Stat Studies for Rademikibart Connect Biopharma Holdings Limited (Nasdaq: CNTB), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, announced that the independent Data Monitoring Committee (DMC) overseeing its Phase 2 Seabreeze STAT asthma and COPD trials evaluating rademikibart, the Company’s next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Ra) antibody, has completed its review of the pre-specified interim analysis of efficacy with no recommendation for change in the sample size. Enrollment will continue as planned with no change in sample size. Rademikibart continues to be well tolerated in these studies of patients experiencing acute exacerbations. The independent DMC reviewed interim data based on a pre-specified analysis of treatment failure at 28 days, the rate of new exacerbations through 28 days, and the change from baseline in FEV1 following treatment of a minimum of 50 patients in each study with at least 28 days of follow-up. The DMC also conducts a review of the safety data for both studies on a regular basis and indicated that it has no safety concerns. To date, there have been no treatment-related serious adverse events or severe adverse events, and no discontinuations due to an adverse event in either study. Connect expects to report topline data from both ongoing Phase 2 Seabreeze STAT studies of rademikibart for acute exacerbations of asthma and of COPD in mid-2026 and plans to move quickly to meet with the U.S. Food and Drug Administration (FDA) to gain alignment on a Phase 3 program. Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Ra), a common subunit of interleukin-4 receptor (IL-4) and interleukin-13 receptor (IL-13). By binding with IL-4Ra, rademikibart can block the functions of IL-4 and IL-13 effectively, thereby blocking the T helper 2 (Th2) inflammatory pathway to achieving the goal of treating Th2 related inflammatory diseases such as atopic dermatitis, asthma and COPD. Connect has granted an exclusive license to Simcere Pharmaceutical Co. Ltd., for rademikibart in Greater China. Under the exclusive license and collaboration agreement, Connect is eligible to receive remaining milestone payments up to an aggregate amount of approximately $110 million upon the achievement of certain development, regulatory and commercial milestones. Connect is also eligible to receive royalties at tiered percentage rates up to low double-digit percentages on net sales in Greater China. 
