Connect Biopharma (CNTB) Study result summary

Study Objectives and Design

• The Seabreeze STAT COPD Phase 2 study evaluated rademikibart as an add-on for acute exacerbations in adults with COPD and type 2 inflammation, enrolling 159 participants randomized 1:1 to rademikibart or placebo plus standard of care.

• The study used design and entry criteria similar to the ABRA study, with high rates of current smokers and rapid enrollment in Eastern Europe.

• Primary endpoint was treatment failure within 28 days, including death, hospital/ED visits, or need to intensify treatment; secondary endpoints included FEV1, new exacerbations, symptom changes, and adverse events.

• The study was powered based on expected treatment failure rates from prior studies.

Efficacy Results

• Rademikibart reduced treatment failure rate by 81% (p=0.0122) and new moderate to severe exacerbations by 85% (p=0.030) vs. placebo through Week 4.

• Achieved a 100% reduction in new hospitalizations or ED visits for acute exacerbations compared to placebo (p=0.0137).

• Clinically meaningful 70 mL greater improvement in FEV1 at Week 4, though not statistically significant.

• Significant reduction in rescue inhaler use and improved symptom scores by Week 2–4.

• Statistically significant improvements in patient-reported outcomes and COPD symptoms.

Safety and Tolerability

• Rademikibart was well tolerated with fewer adverse and serious adverse events than placebo, and no new safety signals observed.

• Lower rate of serious adverse events observed in the rademikibart group.

• One unrelated death occurred in the rademikibart group after 37 days.