Connect Biopharma is slated to present the full results from the Phase 1b study of CPB-201, a novel IL-4Rα antibody, in patients with moderate-to-severe atopic dermatitis (AD) at the 29th European Academy of Dermatology and Venereology Congress (EADV), held virtually October 29-31, 2020.
CBP-201 is a potent monoclonal antibody against IL-4Rα, a cell surface protein required for the signaling of both IL-4 and IL-13, which have significant overlapping biological activities and play key roles in inflammatory diseases mediated by type 2 helper T cells (Th2).
In January 2020, the Company announced positive topline results from its Phase 1b study, showing that CBP-201 administered in cohorts of multiple ascending doses, was safe and well tolerated and has a preliminary efficacy profile that shows rapid benefits across lesional and itch outcome measures, suggesting the potential for differentiation based on a comparison with data from clinical studies of the current standard of care therapy for AD.
Phase 2 dose ranging studies of CBP-201 in patients with moderate-to-severe AD are ongoing.
About the Phase 1b study
The randomized, double-blind, placebo-controlled, multiple dose escalation study conducted in ten sites in Australiaand New Zealand, evaluated the efficacy and safety of CBP-201 in 31 patients with moderate-to-severe AD who have had inadequate response to topical corticosteroids and immunosuppressants. Ten patients per cohort were randomized 4:1 to CBP-201 (75 mg, 150 mg or 300 mg) or matching placebo, and received study treatment once weekly by subcutaneous injection for four consecutive weeks, with follow-up for an additional seven weeks. The primary objective of the study was to assess safety and tolerability of CBP-201 over the 11-week duration of the study, with secondary objectives to evaluate efficacy as determined by multiple assessments (Eczema Area and Severity Index [EASI] scores, IGA scores, affected Body Surface Area [BSA] and Pruritus Numeric Rating Scale [PNRS]) at week 4.