Connect Biopharma’s rademikibart shows efficacy and safety in Phase 2b trial

Connect Biopharma announced positive topline results from the global Phase 2b trial evaluating rademikibart efficacy and safety in adult patients with moderate-to-severe persistent asthma. The trial met its primary endpoint of absolute change from baseline in pre-bronchodilator – BD – forced expiratory volume over one second showing that at Week 12, lung function significantly improved over placebo with both rademikibart doses. The significant improvements seen compared to placebo with both rademikibart 150 mg and 300 mg started as early as Week 1 and were sustained through 24 weeks of treatment. A predefined exploratory analysis showed further improvement in lung function was achieved in patients with eosinophil levels of greater than or equal to 300 cells/microl. Strong and significant improvement in asthma control was also observed. Improvement was evident as early as Week 1 and statistically significant starting at Week 2 through Week 24 for both doses of rademikibart. Treatment with rademikibart showed strong trends toward reduced exacerbations with more than half of all exacerbations during the 24-week study occurring in the placebo group. Treatment with 150 mg and 300 mg Q2W of rademikibart was generally well tolerated. Treatment emergent adverse events were relatively similar across groups, with the most common TEAEs being COVID-19, cough, dyspnea, and wheezing. No new safety signals were observed. The company plans to schedule an End of Phase 2 meeting with the FDA to discuss rademikibart’s Phase 3 regulatory path.