CHENGDU, China, March 28, 2023 – Keymed Biosciences Inc., (“Keymed”) (Stock Code: 02162 HK) is pleased to announce that Phase III confirmatory clinical study of its self-developed Class1 innovative drug CM310 recombinant humanized monoclonal antibody injection in subjects with moderate to severe atopic dermatitis (AD) (trial protocol number: CM310AD005) has completed the data unblinding and preliminary statistical analyses, and both of the co-primary endpoints were achieved successfully. More details will be subsequently released in academic journals/academic conferences.
CM310AD005 is a multi-center, randomized, double-blind, placebo-controlled Phase III confirmatory clinical study to evaluate the efficacy, safety, PK/PD and immunogenicity of CM310 in patients with moderate to severe atopic dermatitis (AD). The eligible subjects were randomized in a 1:1 ratio to receive CM310 (600mg - 300mg Q2W) or placebo. The co-primary endpoints are the proportion of subjects with EASI-75 (Eczema Area and Severity Index (EASI) ≥75% improvement from baseline) and the proportion of subjects with IGA score of 0 or 1 and a deduction of ≥2 points from baseline at Week 16 of treatment.
The results showed that two co-primary endpoints of CM310 were both achieved successfully, and the safety profiles were well and consistent with the historical results. The Group plans to submit for the marketing application of CM310 for the treatment of moderate to severe atopic dermatitis in adults, and communicate with the Center for Drug Evaluation of the National Medical Products Administration (the “NMPA”) of the PRC in the near future.
CM310 is a humanized and highly potent antagonist antibody against interleukin-4 receptor α-subunit (IL-4Rα). It is the first domestically-developed IL-4Rα antibody that received IND approval from the NMPA. By targeting IL-4Rα, CM310 can lead to dual-blockade of interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling. IL-4 and IL-13 are two critical cytokines for initiating type II inflammation. CM310 has demonstrated favorable safety and encouraging efficacy in various historical clinical trials.
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