SAN DIEGO and TAICANG, SUZHOU, China, Oct. 22, 2020 /PRNewswire/ -- Connect Biopharma, a clinical-stage biopharmaceutical company focused on the discovery and development of next-generation immune modulators for the treatment of serious autoimmune and inflammatory diseases, today announced it will 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). The study data, which further validate the safety and efficacy of CBP-201 in this patient population, will be presented in a poster at the 29th European Academy of Dermatology and Venereology Congress (EADV), held virtually October 29-31, 2020.
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 (NCT04444752).
Details of the EADV virtual presentation:
Poster Title: "A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Pharmacokinetics and Preliminary Efficacy of CBP-201 in Adult Patients with Moderate to Severe Atopic Dermatitis (CBP-201AU002)"
Poster Number: PO269
Date and Time: Poster will be available beginning at 3:00AM ET on Thursday, October 29, 2020 through the end of the conference.
About the Phase 1b Trial of CBP-201 in Patients with Moderate-to-Severe AD
The randomized, double-blind, placebo-controlled, multiple dose escalation study conducted in ten sites in Australia and 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.
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). CBP-201 was discovered internally using Connect Biopharma's proprietary Immune Modulation Technology Platform and is under clinical development to treat atopic dermatitis (AD). Additional clinical studies examining the potential of CBP-201 in other Th2 inflammatory diseases that have high unmet medical needs such as Asthma and Chronic Rhinosinusitis with Nasal Polyps, will be initiated shortly.
Results with CBP-201 from a Phase 1b clinical study in adult patients with moderate-to-severe atopic dermatitis, showed a favorable safety profile and exploratory efficacy data found that 42.9% and 50.0% of patients receiving CBP-201 300 mg or 150 mg, respectively, achieved clear/almost clear skin (IGA 0,1) at four weeks. Additionally, skin lesion improvements were rapid, as evidenced as early as one week after dosing and were correlated with a rapid reduction in pruritus intensity and frequency. This suggests the potential for a differentiated efficacy profile, with faster onset of action for CBP-201 compared with data from clinical trials of the current biologic standard of care therapy. Phase 2 dose ranging studies with CBP-201 are now underway to explore the efficacy and safety profile, as well as the potential for dosing every four weeks (NCT04444752).
About Connect Biopharma
Connect Biopharma is a U.S.- and China-based clinical-stage biopharmaceutical company, focused on the discovery and development of next-generation immune modulators to be used in the treatment of serious autoimmune and inflammatory diseases. Leveraging our expertise in the biology of T cell modulation and our proprietary Immune Modulation Technology Platform, a high-throughput screening platform that rapidly and efficiently identifies molecules that target clinically validated disease pathways, we are a company passionate about developing innovative medicines and improving the lives of those suffering from these chronic and debilitating diseases worldwide.
In addition to our lead drug candidates, CBP-201 and CBP-307, we are also advancing three preclinical programs, comprising two small molecule candidates (CBP-174 and CBP-312) and one antibody targeting IL-33 (CBP-233) as treatments for various serious inflammatory conditions. We hold all global rights to our proprietary pipeline and discovery technologies. For additional information about Connect Biopharma, please visit our website at www.connectbiopharm.com
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