Connect Biopharma presents data from Stage 1 of CBP-201 China trial

Connect Biopharma announced that data from Stage 1 of the ongoing pivotal CBP-201 China trial in moderate-to-severe atopic dermatitis showed rapid relief from symptoms, as early as week one in some cases, and no efficacy plateau at Week 16. The study met primary and secondary endpoints with mostly mild-to-moderate adverse effects reported. The data were presented as a late-breaking oral presentation at the American Academy of Dermatology Annual Meeting, taking place in New Orleans, March 17-21. In the study "CBP-201, a next-generation IL-4Ralpha antibody, achieved all primary and secondary efficacy endpoints in the treatment of adults with moderate-to-severe atopic dermatitis: A randomized, double-blind, pivotal trial in China," 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 was 26.9. 54.5% of patients were considered severe, with a baseline Investigators Global Assessment score of 4. At 16 weeks, a greater proportion of patients treated with CBP-201 achieved an IGA score of 0-1 and a 2 point IGA reduction than those on placebo, meeting the study’s primary endpoint. 62.9% percent of CBP-201 patients achieved a 75% skin clearance, versus 23.4% in the placebo group and 35.8% achieved EASI-90. 46.7% of CBP-201 patients achieved a Peak Pruritus-Numerical Rating Scale 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.