prnasiaJanuary 09, 2020
Tag: Moderate-to-Severe Atopic Dermatitis , Connect Biopharma , Positive Topline Data
Connect Biopharma, a clinical-stage biopharmaceutical company aimed at identifying potent and specific immune modulating molecules faster and more efficiently than traditional discovery approaches, today announced positive topline data from the Phase 1b study of its novel IL-4Rα antibody, CBP-201, in patients with moderate-to-severe atopic dermatitis (AD). Results from the study show that CBP-201 has an efficacy profile that is superior to data from clinical studies of the current standard of care therapy for AD after four weeks of treatment, with a favorable safety profile. The company expects to initiate a global Phase 2b clinical study of CBP-201 in patients with moderate-to-severe AD in the first quarter of 2020, which will enroll more than 200 patients and will include up to 90 sites in the United States.
"The results of this Phase 1b trial, while early-stage, demonstrate that CBP-201 provides improvements in all metrics of AD even after only four weeks of treatment," said Mike Royal, MD, Chief Medical Officer of Connect. "We believe the finding that 42.9 percent and 50.0 percent of patients receiving CBP-201 300 mg or 150 mg, respectively, achieved clear/almost clear skin at four weeks is very compelling, especially when compared with data from clinical trials of the current standard of care therapy, in which only 22 to 28 percent of patients on a placebo-adjusted basis achieved this improvement after 16 weeks of treatment. Additional data from the planned Phase 2b study will provide important insight into the role that CBP-201 may play in advancing the care of individuals living with moderate-to-severe AD."
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.
"We are extremely pleased that CBP-201 demonstrated excellent tolerability and rapid onset of efficacy in patients with moderate-to-severe AD after just four weeks of treatment," said Dr. Zheng Wei, co-founder and CEO of Connect Biopharma. "The emerging safety and efficacy profiles of CBP-201 continue to support its best-in-class potential as a treatment option. The potential for dosing every four weeks with CBP-201 compared with every two weeks with the approved biologic therapy, coupled with superior efficacy and a favorable safety profile, would position CBP-201 for both clinical and commercial success. We look forward to confirming these promising Phase 1b results in the Phase 2b study that is expected to begin in the first quarter of 2020."
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