Results from study in adult patients with moderate-to-severe AD presented at EADV Congress
SAN DIEGO and TAICANG, SUZHOU, China, Oct. 29, 2020 /CNW/ -- 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 presented for the first time at a scientific meeting, the data set from its completed Phase 1b study of CBP-201, a novel antibody against IL-4Rα. These results show a well tolerated and favorable safety profile out to week 11 and rapid, early and continued improvements in multiple efficacy assessments as well as in Dermatology Life Quality Index (DLQI) scores, out to the end of dosing at week 4. The data are being presented today in a poster at the European Academy of Dermatology and Venereology Congress (EADV), which is being held virtually October 29 -31, 2020.
Based on a comparison with published data from studies of competitor therapies in patients with moderate-to-severe AD, Connect Biopharma believes that CBP-201 may have a more rapid onset of action and provide earlier relief of AD symptoms, as well as early and continuous improvements in patient quality of life beginning only one week after dosing. These data support the further evaluation of CBP-201's effects in an ongoing dose-ranging study in patients with moderate-to-severe AD (NCT04444752)
"Despite the availability of corticosteroids and newer biologic therapies, many patients with moderate-to-severe AD continue to have unmet need and could benefit from additional treatment options," said Dr. Zheng Wei, co-founder and CEO of Connect Biopharma. "The safety and efficacy results seen in this Phase 1b study and, in particular, the rapid, early and continuous improvement in AD symptoms and patient quality of life observed, suggest that CBP-201 has the potential to provide superior efficacy in AD with faster onset of action, and less frequent dosing compared with the current standard of care approved for the treatment of moderate-to-severe AD. We believe that CPB-201 has best-in-class potential in this indication."
Key Trial Results
Favorable safety and tolerability profile at 11 weeks
Early, rapid and continued improvements in multiple efficacy assessments
Early, rapid and continued improvement in DLQI
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 (EASI, IGA, affected BSA and PNRS) at week 4.
AD, a common condition that can have multiple negative effects on the lives of affected individuals, is a chronic inflammatory disorder characterized by eczematous skin lesions, itch, localized pain, and sleep disturbances. It is also a common condition, occurring in 10-15% of children and 2-4% of adults. Approximately 30% of individuals with AD have moderate-to-severe disease. Patients with moderate-to-severe AD who are not helped by topical corticosteroids continue to have significant unmet needs.
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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SOURCE Connect Biopharmaceuticals
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