Connect Biopharma Holdings Limited announced 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 < 0.001 for both) and were sustained through 24 weeks of treatment (p = 0.001 and p < 0.001, respectively). A predefined exploratory analysis showed further improvement in lung function was achieved in patients with eosinophil levels of = 300 cells/µl. Strong and significant improvement in asthma control was also observed.

The absolute placebo-adjusted changes from baseline in the Asthma Control Questionnaire (ACQ) score at Week 24 were -0.44 (p < 0.001) in the rademikibart 150 mg group and -0.33 (p < 0.01) in the rademikibart 300 mg group. Improvement was evident as early as Week 1 and statistically significant starting at Week 2 through Week 24 for both doses of rademikibart. Although the study was not powered to detect differences in exacerbations, 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 (25 exacerbations vs.

11 and 13 in patients receiving rademikibart 150 mg and 300 mg, respectively). Additionally, there were strong trends toward prolonging the time to first exacerbation in both rademikibart groups compared to placebo. Treatment with 150 mg and 300 mg Q2W of rademikibart was generally well tolerated.

Treatment emergent adverse events (TEAEs) (= 5% of subjects) were relatively similar across groups, with the most common TEAEs being COVID-19, cough, dyspnea, and wheezing. Of note, this trial was started during the worldwide COVID-19 pandemic and COVID-19 adverse events were noted across all treatment groups. No new safety signals were observed.

The Company plans to schedule an End of Phase 2 (EoP2) meeting with the U.S. Food and Drug Administration to discuss rademikibart?s Phase 3 regulatory path. Additionally, the Company plans to submit detailed results from this study for presentation at a future medical congress.