Key Milestone Reached in Catalyst’s Subcutaneous Factor IX Program
Catalyst Biosciences, Inc. recently announced it has achieved a key milestone under its collaboration with ISU Abxis to advance the Factor IX program toward its first human clinical trial. 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 in which 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. Catalyst’s collaborator, ISU Abxis (KOSDAQ: 086890), plans to initiate a Phase 1/2 proof-of-concept study with single and multiple subcutaneous injections in individuals with severe hemophilia B in the second quarter of 2017.
“Individuals with severe hemophilia B will experience abnormal bleeding – not just after an injury, but spontaneously into potentially any organ, joints or muscles. Without preventative treatment or prophylaxis, these individuals may experience several spontaneous bleeding episodes per month,” said Nassim Usman, PhD, President and Chief Executive Officer of Catalyst. “Our vision is to prevent bleeding with the stabilization and normalization of clotting levels using more convenient subcutaneous dosing.”
Catalyst has a collaboration with ISU Abxis to advance the development of CB 2679d/ISU304 through a Phase 1/2 proof-of-concept study in individuals with severe hemophilia B. After Phase 1/2, ISU Abxis has an option for exclusive commercial rights in South Korea and a profit share on ex-South Korean commercialization. Catalyst retains full development and commercial rights for CB 2679d/ISU304 outside of South Korea. Under the license agreement, the next potential milestone payment is for the first patient enrolled in the Phase 1/2 trial.
CB 2679d/ISU304 is a next-generation coagulation Factor IX variant that is IND-approved in South Korea. Catalyst believes that CB 2679d/ISU304 may allow for subcutaneous prophylactic treatment of individuals with hemophilia B. Learn more about Factor IX.
Hemophilia, for which there is no cure, is a rare but serious bleeding disorder that results from a genetic or an acquired deficiency of a protein required for normal blood coagulation. Individuals with hemophilia suffer from spontaneous bleeding episodes as well as substantially prolonged bleeding times upon injury. Learn more about hemophilia.
Catalyst is a clinical-stage biopharmaceutical company focused on developing novel medicines to address hematology indications. Catalyst is focused on the field of hemostasis, including the subcutaneous prophylaxis of hemophilia and facilitating surgery in individuals with hemophilia. For more information, visit www.catalystbiosciences.com.
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