Conoa-B (02162) issued an announcement. The company is pleased to announce that its Class 1 new drug, CM310, recombinant humanized monogram...
Zhitong Finance App News, Conoa-B (02162) issued an announcement. The company is pleased to announce that the Phase III clinical study of its Class 1 new drug, CM310, a recombinant humanized monoclonal antibody (sipuqibimab) injection to treat seasonal allergic rhinitis (SAR), has completed data decontamination and statistical analysis of double-blind treatment period data, and the clinical data has reached the main end.
This clinical trial is a multi-center, randomized, double-blind, placebo-controlled phase III study. It is mainly used to confirm the efficacy and safety of spiquirizumab injections in adult patients with seasonal allergic rhinitis with poor control of nasal glucocorticoids or other treatments. This phase III clinical study included a total of 108 subjects during the pollen season. Using the research center as a stratification factor, they were treated with septicumab 600 mg (first dose) +300 mg and placebo respectively, once every 2 weeks, for a total of 2 treatments, and observed for 8 weeks during the safe period. The main end point of the study was the average change in the total daily retrospective nasal symptom score (rTNSS) for 2 weeks of treatment.
The study results showed that the phase III clinical trial data were positive, and the main endpoints were fully met. Spuchibimab was significantly superior to the placebo group, had highly significant statistical differences, and was safe.
According to reports, spochibimab (R&D code CM310) is an efficient, humanized antibody targeting the interleukin 4 receptor alpha subunit (IL-4Rα). It is the first IL4Rα antibody produced domestically and approved by the National Drug Administration for clinical trials. By targeting IL-4Rα, spoximab can double block the signal transduction of interleukin 4 (IL-4) and interleukin 13 (IL-13). IL-4 and IL-13 are two key cytokines that cause type II inflammation. Spuquipimab has shown good safety and encouraging efficacy in many previous clinical trials. Its application for marketing license to treat moderate to severe atopic dermatitis in adults was accepted by the China Drug Administration on December 7, 2023, and included in the priority review and approval process.