Business
Connect Biopharma Announces Publication of Positive Data from Global Phase 2 Trial of Rademikibart in Patients with Moderate-to-Severe Uncontrolled Asthma
– Rademikibart demonstrated rapid onset of action with significant improvements in lung function observed at one week and maintained through 24 weeks – – In
About this update from Connect Biopharma Holdings Limited
[{"type":"text","content":"– Rademikibart demonstrated rapid onset of action with significant improvements in lung function observed at one week and maintained through 24 weeks – – In patients with eosinophilic-driven asthma (≥300 eosinophils/µL) receiving rademikibart for 24 weeks, the mean difference from placebo in forced expiratory volume was +420 mL, amongst the largest increases reported for a biologic – SAN DIEGO, March 31, 2025 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care of asthma and Chronic Obstructive Pulmonary Disease (COPD), today announced the online publication of positive results from the global Phase 2 trial of rademikibart in patients with moderate-to-severe uncontrolled asthma in the American Journal of Respiratory and Critical Care Medicine (AJRCCM). These data highlight rademikibart’s potential as a novel biologic treatment option for patients with asthma and Type 2 inflammation, demonstrating rapid onset of action, sustained improvement in forced expiratory volume in one second (FEV1), and clinically important reductions in annual exacerbation rates. In the global Phase 2 trial (CBP-201-WW002), 322 adult patients with moderate-to-severe, persistent, uncontrolled asthma were randomized 1:1:1 to two rademikibart groups (150 mg or 300 mg every 2 weeks, following a 600 mg loading dose) or placebo, administered subcutaneously, for 24 weeks. Two-thirds of the randomized patients were treated in the United States. Improvement in lung function based on the primary endpoint of prebronchodilator FEV1 was clinically meaningful and highly statistically significant, beginning at week one following the 600 mg loading dose and sustained through 24 weeks of treatment: Significant increases in FEV1 were observed in both rademikibart dose groups for all high eosinophil count subgroups of patients (i.e., subgroups ≥150 cells/µL at baseline, the initial protocol-specified lower limit entry criterion).At Week 24, in patients with ≥300 eosinophils/µL at baseline receiving rademikibart 300 mg (N=40), the mean difference from placebo in FEV1 was +420 mL; the Week 1 FEV1 improvement in these patients was +312 mL1.Consistent with the improved airway function, patients receiving rademikibart had substantially fewer acute exac...