Keymed Biosciences Inc. announced that the Phase III clinical study of its Class 1 innovative drug CM310 recombinant humanized monoclonal antibody (Stapokibart) injection for the treatment of seasonal allergic rhinitis (SAR) has completed the unblinding of data from the double-blind treatment period and the statistical analysis, which shows that the primary endpoints are achieved. This clinical trial is a multi-center, randomized, double-blind, placebo-controlled phase III study, mainly aimed at confirming the efficacy and safety of Stapokibart injection in adult patients with uncontrolled SAR by nasal glucocorticoids or other treatments. This Phase III clinical study enrolled a total of 108 subjects during the pollen season, with the research center serving as the stratification factor.

The subjects were randomized in a 1:1 ratio to receive 600mg (initial dose) + 300mg of Stapokibart or placebo, once every two weeks (Q2W), total two doses in the treatment period, followed by an 8-week safety observation period. The primary endpoints of the study were the mean change from baseline in daily reflective total nasal symptom score (rTNSS) in 2 weeks. The results of the Phase III clinical trial are positive with primary endpoints achieved.

Stapokibart is significantly superior to placebo group with statistically significant differences and demonstrates a favorable safety profile. Stapokibart (R&D code: CM310) is a high-efficient, humanized antibody targeting the interleukin-4 receptor alpha subunit (IL-4R), the first domestically produced IL-4R antibody receiving clinical trial approval from the National Medical Products Administration. By targeting IL-4R, Stapokibart can block both interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling.

IL-4 and IL- 13 are two key cytokines that trigger type II inflammation. Stapokibart has shown a good safety profile and encouraging efficacy in a number of previous clinical trials. New drug application of Stapokibart for the treatment of moderate-to-severe atopic dermatitis in adults was accepted by the National Medical Products Administration and granted priority review on December 7, 2023.