Rademikibart achieved all primary and secondary endpoints in a randomized pivotal trial for moderate-to-severe AD in China.

Four new studies support the efficacy and safety of rademikibart in atopic dermatitis (AD), Connect Biopharma reports.

Rademikibart (CBP-201), a next-generation IL-4Rα antibody, achieved all primary and secondary endpoints in a randomized pivotal trial for moderate-to-severe AD in China.

This poster presentation reported the Week 16 primary (IGA 0/1) and key secondary efficacy (EASI, PR-NRS, DLQI) outcomes and key safety data demonstrating that rademikibart achieved all endpoints in the primary analysis population of adults with moderate-to-severe AD.

In related news, Eczema Area and Severity Index (EASI) scores improved, and encouraging safety and tolerability were observed, across 16 weeks of treatment with rademikibart for moderate-to-severe atopic dermatitis.

This poster included new efficacy data showing highly significant improvement with rademikibart in total EASI score change and in EASI score per AD sign in the primary analysis population, as well as new safety data indicating that rademikibart was well tolerated.

What’s more, improvements in investigator-rated outcomes across 16 weeks of treatment were seen with rademikibart (CBP-201) for moderate-to-severe AD. 

This poster presentation showed the time course of the statistically significant improvements in investigator-assessed outcomes with rademikibart across the initial 16-week treatment period in the adult population. Treatment with rademikibart led to rapid improvements in IGA 0/1, EASI, BSA and SCORAD, all without plateauing by Week 16.

And improvements in patient-reported outcomes (PROs) were seen with rademikibart for moderate-to-severe atopic dermatitis across 16 weeks.

The poster discussed the statistically significant improvements observed in PROs, as assessed by Peak Pruritus Numerical Rating Scale(PP-NRS), Dermatology Life Quality Index (DLQI), and Patient-Oriented Eczema Measure (POEM) questionnaires, with rademikibart treatment over the initial 16-week treatment period in adult population.

All of the studies were presented at the 25th World Congress of Dermatology in Singapore.

“We were excited to share further data regarding rademikibart’s efficacy and safety, from what is the largest readout of an AD trial in China to date.” says Zheng Wei, Ph.D., Co-Founder and Chief Executive Officer of Connect Biopharma, in a news release. “Rademikibart not only yielded highly significant efficacy responses and was well tolerated, but the improvements seen were consistent across both investigator- and patient-reported outcomes as well. We look forward to the readout at the end of the 36-week maintenance part of the trial by the end of 2023.”