Catalyst Biosciences reports data from Phase 1/2 trial for hemophilia B
Catalyst Biosciences announced positive clinical data from the first Cohort of its ongoing Phase 1/2 proof-of-concept clinical trial in individuals with severe hemophilia B. Cohort 1 results demonstrate that an intravenous dose of CB 2679d is approximately 22 times more potent than an intravenous dose of BeneFIX as measured by activity levels using a one-stage clotting assay; and the average time that CB 2679d stayed in the circulation was significantly longer at 34 hours compared with BeneFIX at 25 hours. These potency results "support that CB 2679d has the potency advantage needed to be delivered as a convenient subcutaneous prophylactic therapy to prevent spontaneous bleeding in individuals with Hemophilia B". The clinical trial will document the subcutaneous bioavailability and clotting ability of CB 2679d achieved with single intravenous and subcutaneous dosing cohorts, followed by daily subcutaneous injections of CB 2679d in the fifth cohort. Interim, top-line results of this open-label study are expected by the end of 2017 and complete trial results in early 2018.