Connect Biopharma Reports Topline Phase 2 COPD Results

What Happened
Connect Biopharma Holdings Ltd filed an 8-K on September 30, 2026 announcing topline results from its global Phase 2 study of rademikibart (an anti‑IL‑4Rα antibody) as an add‑on treatment for acute exacerbations in adults with COPD and type 2 inflammation. The randomized, double‑blind, placebo‑controlled trial enrolled 159 participants (eosinophils ≥300 cells/µL) randomized 1:1 to a single subcutaneous dose of rademikibart or placebo plus standard of care. The Company also furnished a press release and a corporate presentation as exhibits to the filing.

Key Details

• Study population: 159 participants with eosinophil count ≥300 cells/µL experiencing an acute COPD exacerbation; randomized 1:1.
• Primary endpoint: treatment failure through 28 days (death, hospital/ED readmission, unscheduled medical visit, or intensified pharmacologic treatment).
• Topline efficacy through Week 4: treatment failures reduced by 81% (p=0.0122); new moderate/severe exacerbations reduced by 85% (p=0.030); ED visits and hospital admissions for new exacerbations reduced by 100% (p=0.0137).
• Symptoms and lung function: significant reductions in rescue inhaler use Weeks 2–7 and improved COPD symptom score at Week 2 (p=0.0197); a 70 mL greater FEV1 improvement at Week 4 (p=0.1607).
• Safety: rademikibart was well tolerated with no new safety signals; overall incidence of adverse events and serious adverse events was lower in the rademikibart arm versus placebo.

Why It Matters
These topline results indicate rademikibart produced large, statistically significant short‑term reductions in treatment failures and exacerbations in a biomarker‑defined COPD group (eosinophils ≥300). For investors, the data are material because they speak to both efficacy and a favorable safety profile in this Phase 2 setting; however, the filing does not specify next regulatory or Phase 3 plans. The company’s press release and presentation are included as exhibits for more detail.