Connect Biopharma Announces Publication of Positive Data from Global Phase 2 Trial of Rademikibart in Patients with Moderate-to-Severe Uncontrolled Asthma

Core Insights - Connect Biopharma announced positive results from the global Phase 2 trial of rademikibart, indicating its potential as a novel biologic treatment for asthma and Type 2 inflammation, with significant improvements in lung function and reduced exacerbation rates [1][6]. Group 1: Trial Results - The Phase 2 trial involved 322 adult patients with moderate-to-severe uncontrolled asthma, randomized to receive either rademikibart (150 mg or 300 mg every 2 weeks after a 600 mg loading dose) or placebo for 24 weeks [2]. - Significant improvements in forced expiratory volume in one second (FEV1) were observed, with a mean difference from placebo of +420 mL in patients with eosinophils ≥300 cells/µL at baseline [5]. - Rademikibart demonstrated rapid onset of action, with improvements in FEV1 beginning at week one and sustained through 24 weeks [1][2]. Group 2: Safety and Efficacy - Rademikibart was generally well-tolerated, with most treatment-emergent adverse events being mild or moderate, and no serious adverse events related to the treatment [5]. - No eosinophilia-related adverse events were reported, contrasting favorably with other biologics like dupilumab, which had a 13% incidence in similar patient subgroups [5][6]. - The treatment resulted in fewer acute exacerbations compared to placebo, with 24 events in 214 patients receiving rademikibart versus 26 events in 108 patients receiving placebo [5]. Group 3: Future Prospects - Based on the trial data, Connect Biopharma received FDA agreement to advance rademikibart into Phase 3 trials for asthma maintenance treatment [3]. - The company sees significant opportunities to study rademikibart in the critical period following acute exacerbations of asthma or COPD, where current therapies have not been systematically studied [6]. - Rademikibart has the potential to address the needs of approximately 1 million asthma patients and 1.3 million COPD patients in the U.S. who experience acute exacerbations annually [7].