Connect Biopharma's Rademikibart Shows Rapid Lung Function Improvement in Phase 1 Study
Event summary
- Connect Biopharma's Phase 1 study of IV rademikibart showed rapid improvement in FEV1 in asthma and COPD patients, with mean improvements of ~200-400 mL maintained through Day 29.
- A single 300 mg 2-minute IV push of rademikibart produced clinically important FEV1 increases of 100-400 mL as early as 15 minutes post-dosing.
- The study demonstrated that rademikibart was generally well-tolerated with no serious adverse events.
- Connect Biopharma expects to report topline data from Phase 2 Seabreeze STAT studies in mid-2026 and plans to meet with the FDA to align on a Phase 3 program.
The big picture
Connect Biopharma's positive Phase 1 data for IV rademikibart highlights its potential to transform the treatment of acute exacerbations in asthma and COPD, areas with significant unmet need. The rapid bronchodilation effects observed could differentiate rademikibart from current standard of care, which relies on β-agonist bronchodilators and systemic steroids. The company's strategic focus on addressing both acute and chronic aspects of these diseases positions it to capture a significant share of the respiratory disease market, which is expected to grow as the global prevalence of asthma and COPD continues to rise.
What we're watching
- Regulatory Alignment
- Whether Connect Biopharma can successfully align with the FDA on a Phase 3 program for rademikibart, given the unique bronchodilation effects observed.
- Clinical Validation
- The pace at which Phase 2 Seabreeze STAT studies will confirm the rapid bronchodilation effects of rademikibart in acute exacerbations of asthma and COPD.
- Market Differentiation
- How rademikibart's potential best-in-class profile will position it against existing treatments for acute exacerbations in asthma and COPD.