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Connect Biopharma Reports Positive Top-Line Results from the Global Phase 2 Clinical Trial of CBP-201 in Patients with Moderate-to-Severe Atopic Dermatitis
Primary endpoint met with all three CBP-201 arms achieving significant improvements Significant improvements also reported for key secondary endpoints
About this update from Connect Biopharma Holdings Limited
[{"type":"text","content":"Primary endpoint met with all three CBP-201 arms achieving significant improvements Significant improvements also reported for key secondary endpoints including other measures of skin clearance and itch with CBP-201 300mg every two weeks (Q2W) arm The Company intends to initiate a Phase 3 trial program in mid-2022 SAN DIEGO and TAICANG, SUZHOU, China , Nov. 18, 2021 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (\"Connect Biopharma\" or the “Company”), a global clinical-stage biopharmaceutical company dedicated to improving the lives of patients with chronic inflammatory diseases through the development of therapies derived from T cell-driven research, today reported positive topline results from the global Phase 2 clinical trial of CBP-201 administered subcutaneously (SC) to adult patients with moderate-to-severe atopic dermatitis (AD) (NCT04444752). The data show that the trial met its primary efficacy endpoint, with statistically significant improvements in the percentage reduction in the Eczema Area and Severity Index (EASI) score from baseline to Week 16. All three CBP-201 arms (300mg Q2W, 150mg Q2W or 300mg every four weeks (Q4W)) were statistically superior to placebo at Week 16. For EASI secondary endpoints, all three CBP-201 arms showed statistically significant improvements in the proportion of patients achieving at least a 50% or 75% reduction in EASI score from baseline at Week 16, compared with placebo (EASI-50 or EASI-75, respectively). Statistically significant improvements with CBP-201 300mg Q2W over placebo were also seen for other key secondary efficacy endpoints, including the proportion of patients achieving an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) and a reduction of ≥2 points from baseline at Week 16; and change from baseline to Week 16 in weekly average Peak Pruritus Numerical Rating Scale (PP-NRS), as well as a range of other endpoints. CBP-201 was also observed to have a favorable safety profile, with a similar incidence of Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and TEAEs leading to study drug discontinuation reported for CBP-201 treatment and placebo groups. Finally, there were a low reported incidence of injection site reactions (1.8%) and conjunctivitis (3.5%) in patients receiving CBP-201. “We are very ple...