Connect Biopharma asthma study misses primary endpoint, but lung function improves vs placebo
Connect Biopharma reported topline results from its 160-patient Phase 2 Seabreeze STAT Asthma study of rademikibart as an add-on to standard of care for acute asthma exacerbations. The primary endpoint, treatment failure over 28 days, did not reach statistical significance (p=0.153), although the company reported a 66% reduction versus placebo, while the key secondary endpoint, post-bronchodilator FEV1 at Day 7, was statistically significant (p=0.023). The company plans to report COPD study data later this month and then meet with the FDA on a Phase 3 program.
Key points
- Treatment failure rate over 28 days was 2.5% (2 of 79) with rademikibart versus 7.4% (6 of 81) with placebo; p=0.153, not statistically significant
- Post-bronchodilator FEV1 on Day 7 rose 250 mL with rademikibart versus 120 mL with placebo, a 130 mL difference (p=0.023)
- One serious adverse event was reported in the rademikibart arm versus three in the placebo arm; no AEs led to study discontinuation in either arm
- Seabreeze STAT COPD study topline data expected later in September 2026; company plans to engage the FDA on a Phase 3 program afterward
The filing
Written by AI on Nov 9, 2026, 11:44 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 15, 2026.
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