Catalyst Biosciences, Inc. has achieved a key milestone under its collaboration with ISU Abxis to advance the Factor IX program towards its first human clinical trial. ISU Abxis plans to initiate a Phase I/II proof-of-concept study with single and multiple subcutaneous injections in individuals with severe hemophilia B in the second quarter of 2017. Completion of the CB 2679d/ISU304 toxicology studies supported the recent Investigational New Drug (IND) approval by the Korean Ministry of Food and Drug Safety (MFDS) and triggered a milestone payment to Catalyst.CB 2679d/ISU304, a highly potent next-generation coagulation Factor IX variant, has demonstrated the potential to normalize human Factor IX levels with a daily subcutaneous injection in preclinical studies.

Currently approved therapies rely on frequent intravenous infusions where adherence is difficult and convenient access to peripheral veins is a problem, often requiring the use of central venous access devices with the associated risks of infection and thrombosis. Individuals with severe hemophilia B will experience abnormal bleeding - not just after an injury, but spontaneously into potentially any organ, joints or muscles.