Connect Biopharma Announces Positive Preliminary Topline Data from its Global Phase 2 Study of Rademikibart as an Add-on Treatment for Acute Exacerbations in Adult and Adolescent Participants with Asthma and Type 2 Inflammation
Connect Biopharma announced topline results from its 160-patient Phase 2 Seabreeze STAT asthma study, in which rademikibart reduced the 28-day treatment failure rate by approximately 66% versus placebo, although the primary endpoint missed statistical significance (p=0.153). The key secondary endpoint was positive: rademikibart delivered a statistically significant 130 mL greater improvement in post-bronchodilator FEV1 at Day 7 versus placebo (250 mL vs 120 mL; p=0.023), alongside a 50% reduction in emergency department or unscheduled medical visits and a safety profile comparable to placebo.
Key figures
- Drug Name
- rademikibart
- Phase Of Trial
- Phase 2
- Dose mg
- 600
- Fev1 p value
- 0.023
- Saes placebo arm
- 3
- Patients enrolled
- 160
- Fev1 day7 placebo ml
- 120
- Saes rademikibart arm
- 1
- Fev1 day7 rademikibart ml
- 250
- Treatment failure p value
- 0.153
- Treatment failure reduction
- approximately 66%
- Simcere remaining milestones
- approximately $99 million
- High t2 asthma ed visits 2025
- approximately 1.6M
- Ed or unscheduled visit reduction
- 50%
- Fev1 day7 improvement vs placebo ml
- 130
- Treatment failure endpoint significant
- No
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