Rademikibart - (Seabreeze STAT Asthma)

September 15, 2026: Connect Biopharma Holdings Limited (NASDAQ: CNTB) reported topline Phase 2 Seabreeze STAT Asthma results for rademikibart (CBP-201-206) as add-on therapy for acute asthma exacerbations in adults and adolescents with type 2 inflammation. In the 160-patient randomized, double-blind, placebo-controlled study, rademikibart significantly improved post-bronchodilator FEV1 at Day 7 versus placebo: +250 mL vs +120 mL, a 130 mL placebo-adjusted benefit (p=0.023).

The primary endpoint, 28-day treatment failure, was reduced by about 66% versus placebo but did not reach statistical significance (p=0.153), which the company said reflected a lower-than-projected overall treatment failure rate. The company also reported a 50% reduction in emergency department visits or unscheduled medical visits for worsening asthma symptoms.

Rademikibart was described as well tolerated, with no new safety signals, no adverse events leading to discontinuation, and one serious adverse event in the rademikibart arm versus three with placebo.

Upcoming catalyst: Connect expects topline data later in September 2026 from the ongoing Phase 2 Seabreeze STAT COPD study (CBP-201-207) in acute COPD exacerbations with type 2 inflammation, after which it plans to meet with the FDA to align on a Phase 3 program.