Catalyst Biosciences said Tuesday that the completion of the CB 2679d/ISU304 toxicology studies supported the recent investigational new drug approval by the Korean Ministry of Food and Drug Safety, marking a milestone to advance the Factor IX program towards its first human clinical trial.
Catalyst believes that CB 2679d/ISU304, a coagulation Factor IX variant, may allow for subcutaneous prophylactic treatment of individuals with hemophilia B. It has demonstrated the potential to normalize human Factor IX levels with a daily subcutaneous injection in pre-clinical studies. Shares were up 5% in recent trading. The approval triggered a milestone payment to Catalyst. Catalyst said ISU Abxis plans to initiate a phase 1/2 proof-of-concept study with single and multiple subcutaneous injections in individuals with severe hemophilia B in Q2 of 2017.