Connect Biopharma reports positive Phase 2 topline data for rademikibart in COPD
The company said rademikibart cut treatment failure by 81% and new exacerbations by 85% versus placebo in the Seabreeze STAT COPD trial, and plans to seek FDA alignment on Phase 3.
Connect Biopharma Holdings Limited announced on September 30, 2026, that its Phase 2 Seabreeze STAT COPD study of rademikibart met its primary endpoint. The Phase 2 Seabreeze STAT COPD study (CBP-201-207) was a randomized, double-blind, placebo-controlled study of rademikibart as an adjunct to standard of care for acute exacerbations in COPD patients with type 2 inflammation, enrolling 159 participants globally with an eosinophil count of ≥300 cells/μL, randomized 1:1 to a single subcutaneous dose of rademikibart or placebo.1
The primary endpoint was treatment failure, defined as death due to any cause, (re)admission to a hospital for COPD, emergency department (re)visit or unscheduled medical visit for worsening of COPD symptoms, or the necessity to intensify pharmacologic treatment within 28 days after randomization.1
Key results reported by the company included that rademikibart significantly reduced the rate of treatment failure by 81% through Week 4 compared to placebo (p=0.0122), reduced new moderate to severe COPD exacerbations by 85% (p=0.030), and reduced new emergency department visits and hospital admissions by 100% (p=0.0137). The trial also showed reduced rescue inhaler use from Week 2 through Week 7, improved COPD symptom scores at Week 2 (p=0.0197), and a 70 mL greater improvement in FEV1 at Week 4 (p=0.1607), described as clinically meaningful by the company.1 The company said rademikibart was well tolerated with no new safety signals, and the safety profile was comparable to placebo, with a lower incidence of adverse events and serious adverse events in the rademikibart arm.1
CEO Barry Quart said the company plans to engage with the FDA as soon as feasible regarding a Phase 3 registrational development program for rademikibart as an add-on treatment for COPD.1
Connect has granted an exclusive license to Simcere Pharmaceutical Co., Ltd. for rademikibart in Greater China, under which Connect is eligible for up to approximately $99 million in remaining milestone payments and tiered royalties up to low double digits on net sales in that territory.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.