Keymed Biosciences has reported long-term efficacy and safety data of a Phase III clinical trial of the stapokibart injection in patients with moderate-to-severe atopic dermatitis (AD).
Stapokibart (CM310) is a highly efficient, humanised antibody targeting the interleukin-4 receptor alpha subunit (IL-4Rα).
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It is said to be the first domestically manufactured IL-4Rα antibody drug to receive clinical trial approval from the National Medical Products Administration (NMPA).
Stapokibart, by targeting IL-4Rα, can block both interleukin-4 (IL-4) and interleukin-13 (IL-13) signalling, which are two key cytokines that trigger type 2 inflammation.
A total of 500 adult patients were randomised 1:1 to receive stapokibart 300mg or placebo every two weeks for 16 weeks, during the double-blind treatment period.
In the subsequent 36-week maintenance treatment period, patients in the stapokibart group continued the same dose, and patients switching from placebo to stapokibart received stapokibart 300mg for every two weeks.
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By GlobalDataThe trial’s co-primary endpoints were the proportions of patients achieving improvement of ≥75% from baseline in Eczema Area and Severity Index score (EASI-75) and an Investigator’s Global Assessment (IGA) score of 0/1 with a ≥2 point reduction from baseline at week 16.
The multicenter, randomised, double-blind, placebo-controlled phase III trial aimed to assess the stapokibart’s efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity in patients with moderate-to-severe AD.
At week 52, the company noted that EASI-75 was achieved in 92.5% of patients continuing stapokibart and 88.7% of those switching from placebo to stapokibart.
In several previous clinical trials, stapokibart has shown a good safety profile and encouraging efficacy.
Keymed’s new drug application for stapokibart for the treatment of moderate-to-severe atopic dermatitis in adults was granted priority review in December 2023.
Furthermore, stapokibart’s long-term treatment with continuously improved AD symptoms in patients.
