Keymed Biosciences has reported positive safety and efficacy data of CM313 in adult patients with primary immune thrombocytopenia (ITP) as part of an investigator-initiated, single-arm, open-label Phase I/II study.

CM313 is a humanised monoclonal antibody intended for targeting CD38.

The study has been designed to assess the safety and preliminary efficacy of CM313 in treating primary ITP.

As part of the trial, 22 adult patients with primary ITP were enrolled, with 21 completing the eight-week treatment and 16-week follow-up. One subject dropped out after the first infusion.

Results indicated a high response rate, with 95.5% of patients achieving a significant increase in platelet count.

A median cumulative response duration of 23 weeks was also observed in the trial.

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The median time to response was one week, showcasing CM313’s rapid action.

Besides, the durable sustained platelet count response rate was reported to be 63.6%.

A notable reduction in bleeding incidents was observed from 68.2% (15/22) at baseline to 4.8 (1/21) at week eight.

Safety assessments throughout the trial showed that CM313 was well-tolerated by patients.

The majority were able to discontinue other medications due to the restoration of platelet counts.

Previous Phase I/II studies showcased CM313’s encouraging efficacy and favourable safety profile in RRMM and primary ITP patients.

CM313 received Investigational New Drug (IND) approval by China’s National Medical Products Administration.

Earlier this month, Keymed reported long-term efficacy and safety data of a Phase III clinical trial of the stapokibart injection in patients with moderate-to-severe atopic dermatitis (AD).