20 March 2023 | Monday | News
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In the study “CBP-201, a next-generation IL-4Rα antibody, achieved all primary and secondary efficacy endpoints in the treatment of adults with moderate-to-severe atopic dermatitis (AD): A randomized, double-blind, pivotal trial in China (CBP-201-CN002),” researchers reported on results from Stage 1 of the pivotal China trial of CBP-201 in moderate-to-severe AD. This 16-week trial stage included 255 adults in the primary analysis population who received a 600 mg CBP-201 loading dose, followed by 300 mg CBP-201 every two weeks, compared to placebo. Patients on active therapy experienced rapid relief of symptoms, with a reduction in itch at Week 1 and significant improvement in all study endpoints by Week 4, which was sustained to Week 16. Furthermore, there was no plateau in IGA and EASI efficacy response at Week 16.
Specifically, the baseline median Eczema Area and Severity Index (EASI) was 26.9. 54.5% of patients were considered severe, with a baseline Investigators Global Assessment (IGA) score of 4. At 16 weeks, a greater proportion of patients treated with CBP-201 achieved an IGA score of 0-1 (clear or almost clear skin) and a 2 point IGA reduction than those on placebo (30.3% vs. 7.5%), meeting the study’s primary endpoint. 62.9% percent of CBP-201 patients achieved a 75% skin clearance (EASI-75), versus 23.4% in the placebo group and 35.8% achieved EASI-90 (versus 6.3% for placebo). 46.7% of CBP-201 patients achieved a Peak Pruritus-Numerical Rating Scale (PP-NRS) reduction of 3 points, versus 16.7% on placebo, and 35.0% achieved a PP-NRS reduction of 4 points, versus 9.6% in the placebo group. CBP-201 appeared to be well tolerated.
“We are honored to have data from our two CBP-201 atopic dermatitis studies at the prestigious American Academy of Dermatology Annual Meeting, showing rapid and sustained relief,” said Zheng Wei, Ph.D., Co-founder and CEO of Connect Biopharma. “CBP-201 has a highly differentiated profile, which includes a higher binding affinity than other drugs in the class, higher potency and slower target-mediated drug elimination. We believe this could lead to a more flexible 4-week dosing schedule. We look forward to completing the 36-week maintenance data from our CBP-201 China trial, which includes a four-week dosing arm, to further develop this promising new treatment for moderate-to-severe atopic dermatitis, where the unmet need is high and patients have limited dose regimen options.”