Connect Biopharma Holdings Limited (Nasdaq: CNTB) announced topline results from its global Phase 2 study evaluating rademikibart, a next-generation anti-interleukin-4-receptor alpha antibody, as an add-on treatment for acute exacerbations in adults with chronic obstructive pulmonary disease (COPD) and type 2 inflammation.
The study, known as the Seabreeze STAT COPD trial (CBP-201-207), enrolled 159 participants globally with an eosinophil count of 300 cells/μL who had experienced an acute COPD exacerbation. Participants were randomized 1:1 to receive either a single subcutaneous dose of rademikibart or placebo in addition to standard of care.
The primary endpoint was treatment failure, defined as death, hospitalization, emergency department visit, or unscheduled medical visit within 28 days. Key topline results include:
- A significant 81% reduction in the rate of treatment failure through Week 4 compared to placebo (p=0.0122).
- A significant 85% reduction in the rate of new moderate to severe COPD exacerbations through Week 4 compared to placebo (p=0.030).
- A 100% reduction in new emergency department visits and hospital admissions for new exacerbations through Week 4 compared to placebo (p=0.0137).
- A clinically meaningful 70 mL greater improvement in post-bronchodilator FEV1 at Week 4 compared to placebo (p=0.1607).
Additionally, rademikibart significantly reduced the use of rescue inhalers from Week 2 through Week 7 and improved COPD symptoms at Week 2 compared to placebo. The drug was well tolerated with no new safety signals observed; the safety profile was comparable to placebo, with a lower incidence of adverse events and serious adverse events in the rademikibart arm.
Connect Biopharma stated it plans to engage with the U.S. Food and Drug Administration (FDA) to discuss a potential Phase 3 registrational program. The company also noted that 2025 claims data indicate that COPD patients visiting the emergency department generate approximately $6 billion in healthcare costs in the following 30 days.
