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Conoya-B (02162)LightningbaccaratHK) Class 1 new drug CM310 injection showed positive results in phase III clinical trials.LightningbaccaratThe main end point for the treatment of seasonal allergic rhinitis is up to the standard, and the safety performance is good.
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On April 28th, 02162.HK announced that its first class of new drug CM310 recombinant humanized monoclonal antibody (Spozibizumab) injection in the treatment of seasonal allergic rhinitis (SAR) phase III clinical study has successfully completed the double-blind treatment phase data and statistical analysis, and the clinical data reached the main end point. This clinical trial is a multicenter, randomized, double-blind, placebo-controlled phase III study to verify the efficacy and safety of Spozibizumab injection in the treatment of adult patients with seasonal allergic rhinitis who are poorly controlled by nasal corticosteroids or other treatments. The phase III clinical study included 108 subjects during the pollen season. They were randomly assigned to receive 600mg (first dose) plus 300mg or placebo, once every two weeks, according to a random proportion of 1:1. The safety period was observed for 8 weeks. The main end point of the study was the average change of the daily retrospective total nasal symptom score (rTNSS) compared with the baseline for 2 weeks. The announcement revealed that data from phase III clinical trials showed that Spozibizumab was fully up to standard at the main end point with a highly significant statistical difference compared with the placebo group and good safety. Spuqibai monoclonal antibody (R & D code CM310) is a highly effective and humanized antibody against interleukin-4 receptor subunit (IL-4R). It is the first IL4R antibody made in China and approved by the State Drug Administration for clinical trials. By targeting IL-4R, it can double block the signal transduction of IL-4 (IL-4) and IL-13 (IL-13). These two cytokines are the key factors leading to type II inflammation. Spozibizumab has shown good safety and encouraging efficacy in a number of clinical trials. the application for marketing license for the treatment of adult moderate and severe atopic dermatitis was accepted by the State Drug Administration on December 7, 2023 and included in the priority review and approval process. [phase III clinical study of Conoya-B new drug CM310 in the treatment of seasonal allergic rhinitis reached the main end point]
