Catalyst Biosciences says Korean MFDS approves sixth cohort of CB 2679d trial
Catalyst Biosciences announced that the Korean Ministry of Food and Drug Safety, or MFDS, approved the addition of a sixth cohort to the Phase 1/2 trial of CB 2679d in individuals with severe hemophilia B following positive data from the multi-dose Cohort 5 that was disclosed on February 9. Cohort 6 will enroll up to five patients. Each individual will receive a single intravenous loading dose of 75 IU/kg, followed by nine daily subcutaneous doses of 150 IU/kg CB 2679d. The loading dose will be administered 30 minutes before the first subcutaneous dose. The study will be completed in South Korea in coordination with the Company's collaborator ISU Abxis.