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).
Go deeper with GlobalData
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.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
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.
