Connect Biopharma Holdings Limited announced topline results from its global Phase 2 study of rademikibart for treating acute asthma exacerbations. The study achieved its key secondary endpoint with a statistically significant improvement in lung function. While the drug reduced the primary endpoint of treatment failure by 66%, the result was not statistically significant due to a lower-than-projected event rate in the trial.
Key Details
- Statistically Significant Lung Function Improvement: The study met its key secondary endpoint, showing a 130 mL greater improvement in lung function (FEV1) versus placebo at Day 7 (p=0.023).
- Primary Endpoint Missed Significance: The primary endpoint, reduction in treatment failure over 28 days, missed statistical significance (p=0.153) despite a 66% reduction compared to placebo.
- Next Steps: The company plans to meet with the FDA to discuss a Phase 3 program and expects to report topline data from a related COPD study later this month.