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Connect Biopharma Announces Positive Rademikibart Global Phase 2b Topline Results in Adult Patients with Moderate-to-Severe Persistent Asthma
The global trial met its primary endpoint showing both doses of rademikibart treatment significantly improved lung function at Week 12The significant
About this update from Connect Biopharma Holdings Limited
[{"type":"text","content":"The global trial met its primary endpoint showing both doses of rademikibart treatment significantly improved lung function at Week 12The significant improvement in lung function was observed as early as Week 1 and was sustained through Week 24 with both doses of rademikibartSignificant improvement in asthma control occurred early and was sustained through Week 24 for both doses of rademikibartSafety results suggest rademikibart was generally well toleratedA conference call and webcast presentation to discuss the data will be held today at 8:30 a.m. ET, details below SAN DIEGO, CA and TAICANG, China, Dec. 12, 2023 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma” or the “Company”), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, announced today positive topline results from the global Phase 2b trial evaluating rademikibart efficacy and safety in adult patients with moderate-to-severe persistent asthma. This Phase 2b trial was a global, multicenter, randomized, double-blind, placebo-controlled study conducted in 79 sites in the United States, Poland, Hungary, China and South Korea with 322 patients randomized 1:1:1 to rademikibart 150 mg every two weeks (Q2W) with a loading dose of 600 mg (n=106), rademikibart 300 mg Q2W with a loading dose of 600 mg (n=108) and placebo (n=108). Two-thirds of the randomized patients were treated in the United States. The trial met its primary endpoint of absolute change from baseline in pre-bronchodilator (BD) forced expiratory volume over one second (FEV1) showing that at Week 12, lung function significantly improved over placebo with both rademikibart doses (see table below). The significant improvements seen compared to placebo with both rademikibart 150 mg and 300 mg started as early as Week 1 (p Full Analysis Set (primary endpoint)Patients with baseline Eosinophils ≥ 300 cells/µL (exploratory endpoint) Placebo(n=96)Rademikibart Q2WPlacebo(n=37)Rademikibart Q2W 150 mg (n=96)300 mg (n=86)150 mg (n=33)300 mg (n=41)LS Mean Change from Baseline in pre-BD FEV1 at Week 1295 mL235 mL283 mL-8 mL235 mL320 mLDifference in LS Means 140 mL(p = 0.005)189 mL(p 243 mL(p 328 mL(p Strong and significant improvement ...