China-based Keymed Biosciences Inc., a prominent player in the biopharmaceutical industry (HKG: 2162), has announced that its IL-4Rα monoclonal antibody (mAb) drug candidate, CM310, has successfully reached its primary endpoints in a confirmatory Phase III clinical study for the treatment of moderate to severe atopic dermatitis (AD).
Phase III Study Design and Outcomes
The Phase III confirmatory study, a multi-center, randomized, double-blind, placebo-controlled trial, was designed to evaluate the efficacy, safety, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) effects, and immunogenicity of CM310 in patients with moderate to severe AD. Participants were randomly assigned to receive either CM310 (600mg-300mg Q2W) or a placebo. The primary endpoints included the rate of achieving an eczema area and severity index (EASI) – 75 (a decrease of at least 75% from baseline EASI score) at 16 weeks of treatment, and reaching an investigator’s global assessment (IGA) score of 0 or 1 with a decrease of at least 2 points from baseline. The study demonstrated that CM310 successfully met its main efficacy endpoints, exhibited good safety profiles, and was consistent with previous findings.
Plans for Submission and Future Outlook
Following these positive results, Keymed Biosciences plans to engage in discussions with the National Medical Products Administration (NMPA) about the submission of the CM310 listing application for the treatment of adult moderate to severe atopic dermatitis in the near future. CM310 has previously shown promising safety and efficacy in multiple clinical trials, reinforcing the company’s commitment to advancing treatments for AD.-Fineline Info & Tech
