Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma or the Company), a global clinical-stage biopharmaceutical company developing T cell-driven therapies to treat inflammatory diseases, announced topline results for the primary analysis population of the pivotal trial of the Company’s lead candidate, CBP-201, in patients with moderate-to-severe atopic dermatitis (AD) in China. This multi-center, randomized, double-blind, parallel group, placebo-controlled trial is evaluating the efficacy and safety of CBP-201 as well as the potential for an extended CBP-201 dosing interval during the maintenance phase of treatment.
The primary endpoint of IGA of 0 or 1 with at least 2 grades of reduction at Week 16 from baseline was significantly greater for the CBP-201 (300 mg every two weeks) group with 30.3% of patients showing improvement compared to 7.5% for the placebo group (p < 0.001). CBP-201 also met key secondary endpoints, including 83.1%, 62.9% and 35.8% of patients achieving a 50%, 75%, 90% reduction in the Eczema Area and Severity Index score (EASI-50, EASI-75, EASI-90) from baseline compared to 41.1%, 23.4% and 6.3% for the placebo group (p < 0.001), respectively. Significant improvement in pruritus with 35.0% of patients experiencing a reduction of 4 or greater on the Peak Pruritus-Numerical Rating Scale (PP-NRS) compared to 9.6% for placebo (p < 0.001). The percent change from baseline compared to placebo showed a statistically significant improvement in itch (as measured by PP-NRS) one week after the first dose.
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