Rademikibart - (Seabreeze STAT Asthma)

Aug. 12, 2026: Connect Biopharma Holdings Limited (NASDAQ: CNTB) said it completed enrollment in the Phase 2 Seabreeze STAT Asthma and Seabreeze STAT COPD studies of rademikibart as adjunct treatment for acute exacerbations in patients with type 2 inflammation, with topline results from both trials expected in September 2026. Both randomized, double-blind, placebo-controlled studies use 28-day treatment failure rate as the primary endpoint and Week 1 post-bronchodilator FEV1 as the key secondary endpoint.

Seabreeze STAT Asthma enrolled 160 adult/adolescent participants with asthma and eosinophils ≥300 cells/μL after an acute exacerbation; Seabreeze STAT COPD enrolled 159 participants with COPD and eosinophils ≥300 cells/μL after an acute exacerbation. The company said the readouts should help determine potential Phase 3 endpoint and sample size requirements, and it plans to meet with the FDA afterward to align on a potential Phase 3 program.

Also in August 2026, Connect initiated Seabreeze STAT IV, an open-label, single-arm Phase 2 trial of IV rademikibart in 40 asthma or COPD patients requiring an urgent healthcare visit, designed to bridge 600 mg subcutaneous to 300 mg IV push administration.

Cash, cash equivalents, and short-term investments were $31.5 million as of June 30, 2026, with runway expected for at least one year from the release date.