Connect Biopharma finishes enrollment in Phase 2 asthma, COPD exacerbation studies

Connect Biopharma Holdings Limited reported on August 12, 2026 that it has completed enrollment of the Phase 2 Seabreeze STAT asthma and COPD studies evaluating the safety and efficacy of rademikibart as an adjunct treatment for acute exacerbations.¹ The company said topline data from both studies are expected in September 2026, which should help determine a potential Phase 3 endpoint and sample size requirements.¹ Following topline results, the Company plans to meet with the FDA to gain alignment on a Phase 3 program.¹

The asthma study, "Seabreeze STAT Asthma," is a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of rademikibart as an adjunct to standard of care for acute exacerbations in adult and adolescent participants with asthma and type 2 inflammation.¹ It has enrolled 160 participants globally with an eosinophil count of ≥300 cells/μL who have experienced an acute asthma exacerbation.¹ The companion COPD study has enrolled 159 participants globally with the same eosinophil threshold who have experienced an acute COPD exacerbation.¹ Both trials use treatment failure rate over 28 days following an acute exacerbation as the primary endpoint.¹

In August 2026, Connect also initiated the Phase 2 Seabreeze STAT IV study, an open-label, single-arm trial to evaluate intravenous (IV) rademikibart as an add-on treatment for an acute exacerbation in 40 participants with asthma or COPD with type 2 inflammation who require an urgent healthcare visit¹, and the trial is designed to bridge 600 mg subcutaneous to 300 mg IV push administration for treating acute exacerbations.¹

On the balance sheet, cash, cash equivalents and short-term investments were $31.5 million as of June 30, 2026¹, and the company said this will be sufficient to meet its anticipated cash requirements for a period of at least one year from the date of this release.¹ Under its license agreement with Simcere covering Greater China, Connect is eligible to receive remaining milestone payments up to an aggregate amount of approximately $99 million upon the achievement of certain development, regulatory and commercial milestones.¹