Keymed reveals positive data of CM313 in immune thrombocytopenia trial

Keymed Biosciences has released promising results from a Phase I/II study of CM313 in adults with primary immune thrombocytopenia (ITP). This investigator-initiated, single-arm, open-label trial evaluated CM313, a humanized monoclonal antibody targeting CD38, for safety and initial efficacy in treating ITP.

Twenty-two adult patients were enrolled, with 21 completing the eight-week treatment and follow-up; one withdrew after the first infusion. Results showed a strong response, with 95.5% achieving significant platelet count increases. The median time to response was one week, indicating rapid action. A durable platelet count response rate of 63.6% was observed.

Bleeding incidents decreased from 68.2% at baseline to 4.8% at week eight. CM313 was well-tolerated, allowing many patients to discontinue other medications due to restored platelet counts. Previous Phase I/II studies in RRMM and primary ITP patients also showed CM313's promising efficacy and safety.

CM313 received Investigational New Drug (IND) approval from China’s National Medical Products Administration. Recently, Keymed reported long-term efficacy and safety data from a Phase III trial of stapokibart injection for moderate-to-severe atopic dermatitis (AD).