Catalyst Biosciences Announces Korean Ministry of Food and Drug Safety Approves Addition of Sixth Cohort to the Phase 1/2 Trial of CB 2679d/ISU304

Catalyst Biosciences (Nasdaq:CBIO), a clinical-stage biopharmaceutical company focused on developing novel medicines to address hematology indications, today announced that the Korean Ministry of Food and Drug Safety (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.

As quoted in the press release:

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.

“The addition of this sixth cohort will allow us to build on the progressive increase in Factor IX activity levels, from severe to mild hemophilia, that we observed after six daily subcutaneous doses in Cohort 5 of this Phase 1/2 trial,” said Nassim Usman, Ph.D., chief executive officer of Catalyst. “The Cohort 6 design will also allow us to evaluate the benefits of a single IV loading dose of CB 2679d. Interim results from this sixth cohort are expected in Q3 2018 with additional data in Q4 2018. Data from this cohort will inform the design of future trials, including the upcoming Phase 2b trial, planned to begin in Q3 2018.”

Click here to read the full press release.