Connect Biopharma Holdings Limited reports no changes after interim Phase 2 Seabreeze STAT analysis of rademikibart in asthma and COPD, with trials continuing as planned.
Written By: Pharmacally Medical News Desk
Connect Biopharma Holdings Limited announced that an independent Data Monitoring Committee (DMC) has completed a pre-specified interim analysis of its ongoing Phase 2 Seabreeze STAT trials evaluating rademikibart in patients with acute exacerbations of asthma and chronic obstructive pulmonary disease (COPD).
The committee recommended no changes to the study design, including sample size, allowing both trials to proceed as planned.
The interim review assessed efficacy endpoints after at least 50 patients in each study completed 28 days of follow-up. These endpoints included treatment failure at day 28, the rate of new exacerbations, and changes in forced expiratory volume in one second (FEV1), a standard measure of lung function.
According to the company, the DMC also conducted routine safety evaluations and reported no concerns. No treatment-related serious or severe adverse events have been observed, and no patients discontinued participation due to adverse events.
Barry Quart CEO and Director of Connect Biopharma stated that the interim findings support continued enrolment without modification. He also noted that rademikibart has been well tolerated so far and may offer differentiated efficacy and safety in patients with type 2 inflammatory asthma and COPD experiencing acute exacerbations.
Topline results from both Seabreeze STAT studies are expected in mid-2026. Following data readout, the company plans to engage with the U.S. Food and Drug Administration to discuss the design of a potential Phase 3 development program.
In earlier studies, rademikibart has shown rapid and sustained improvements in FEV1, and the therapy has also demonstrated positive Phase 3 results in atopic dermatitis, including data presented at the American Academy of Dermatology Annual Meeting, providing broader context for its development across type 2 inflammatory diseases.
About Rademikibart
Rademikibart is a fully human monoclonal antibody that targets interleukin-4 receptor alpha (IL-4Rα), a shared component of the IL-4 and IL-13 signaling pathways. By blocking this receptor, the therapy is designed to inhibit the T helper 2 (Th2) inflammatory pathway, which plays a key role in diseases such as asthma, COPD, and atopic dermatitis.
The drug is being developed as a next-generation biologic therapy aimed at improving outcomes in patients with type 2 inflammatory diseases.
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