China-based biopharmaceutical company Keymed Biosciences Inc. (HKG: 2162) has announced that its IL-4Rα monoclonal antibody (mAb) drug candidate, stapokibart (CM310), has successfully achieved its primary endpoint in a Phase III clinical trial for seasonal allergic rhinitis (SAR).
The Phase III study, which was multi-center, randomized, double-blinded, and placebo-parallel-controlled, aimed to evaluate the efficacy and safety of stapokibart in adult patients with SAR who had inadequate control with nasal corticosteroids or other treatments. The trial enrolled 108 subjects during the pollen season, who were randomly assigned to receive either the first dose of stapokibart 600mg+300mg or a placebo. The primary endpoint was the mean change in daily reflective total nasal symptom score (rTNSS) from baseline after two weeks of treatment. The results were positive, with the primary endpoint met, showing stapokibart to be significantly more effective than placebo with a highly significant statistical difference and exhibiting a good safety profile.
Stapokibart is designed to selectively bind to IL-4Rα, thereby blocking the interaction with IL-4 and IL-13, which are key drivers of the immune response in allergic conditions. The drug has demonstrated favorable safety and promising efficacy across several studies. Additionally, a market filing for stapokibart for the treatment of moderate to severe atopic dermatitis (AD) has been accepted for review by China’s National Medical Products Administration (NMPA) with priority review status.- Flcube.com
