Recent Updates — CNTB

Connect Biopharma Holdings Limited announced positive topline results from its global Phase 2 Seabreeze STAT COPD study evaluating rademikibart, an anti-IL-4Rα antibody, as an add-on treatment for acute exacerbations in adults with COPD and type 2 inflammation. The study enrolled 159 participants randomized 1:1 to receive a single subcutaneous dose of rademikibart or placebo. Rademikibart significantly reduced the rate of treatment failure by 81% (p=0.0122) and new moderate-to-severe exacerbations by 85% (p=0.030) through Week 4 compared to placebo. The drug also eliminated emergency department visits and hospital admissions for new exacerbations by 100% (p=0.0137), reduced rescue inhaler use, and improved respiratory symptoms. A clinically meaningful 70 mL improvement in FEV1 was observed at Week 4, though it did not reach statistical significance (p=0.1607). The treatment was well-tolerated with no new safety signals. Connect plans to engage the FDA regarding a Phase 3 program. Connect Biopharma Holdings Limited is a clinical-stage biopharmaceutical company focused on developing therapies for inflammatory respiratory diseases.

Connect Biopharma Holdings Limited announced topline results from its global Phase 2 Seabreeze STAT study evaluating rademikibart as an add-on treatment for acute exacerbations in adult and adolescent participants with asthma and type 2 inflammation. The study enrolled 160 patients randomized 1:1 to receive a 600mg dose of rademikibart (n=79) or placebo (n=81). Rademikibart demonstrated a statistically significant increase in post-bronchodilator FEV1 on Day 7 of 250 mL compared to 120 mL with placebo, representing a 130mL greater improvement (p=0.023). The treatment failure rate was reduced by approximately 66% over 28 days compared to placebo (p=0.153), though this endpoint missed statistical significance due to a lower-than-projected overall failure rate. Additionally, there was a 50% reduction in emergency department visits or unscheduled medical visits for worsening asthma symptoms compared to placebo. The drug was well tolerated with no new safety signals observed. Connect Biopharma is a clinical-stage biopharmaceutical company focused on developing treatments for inflammatory diseases such as asthma and COPD.