Catalyst Biosciences Announces IND Approval In South Korea For Next-Generation Subcutaneous Factor IX Program

-- Investigational New Drug (IND) approval from Korean Ministry of Food and Drug Safety represents a key milestone in Catalyst’s Factor IX development program --

-- Catalyst’s collaborator, ISU Abxis, plans to initiate a Phase 1/2 proof-of-concept study in individuals with severe hemophilia B in the second quarter of 2017 --

SOUTH SAN FRANCISCO, Calif., March 28, 2017 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (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 Investigational New Drug Application (IND) for CB 2679d/ISU304. Hemophilia is a serious bleeding disorder that results in spontaneous bleeding episodes as well as substantially prolonged bleeding times upon injury.

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. 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.

“We are very pleased with the progress we and our collaborator ISU Abxis have made in advancing this Factor IX candidate towards the clinic and we look forward to the initiation of a Phase 1/2 clinical trial next quarter,” said Nassim Usman, Ph.D., President and Chief Executive Officer of Catalyst. “We believe that stopping bleeding is good, but preventing bleeding is better. CB 2679d/ISU304 has the properties required, including high potency, to allow for daily subcutaneous injection with the potential to achieve stable and normal Factor IX clotting levels.”

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.

About Factor IX

CB 2679d/ISU304 is a next-generation coagulation Factor IX variant that is IND-approved in South Korea. CB 2679d/ISU304 has exhibited enhanced procoagulant activity, improved efficacy in inhibiting blood loss, and prolonged duration of action in bleeding and non-bleeding preclinical models compared with other Factor IX products on the market. Catalyst believes that CB 2679d/ISU304 may allow for subcutaneous prophylactic treatment of individuals with hemophilia B.

About Hemophilia and Factor Replacement Therapy

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. There are two major types of hemophilia, A and B, that are caused by alterations in Factor VIII or Factor IX genes, respectively, with a corresponding deficiency in the affected proteins. The prevalence of hemophilia A and B in the United States is estimated to be around 20,000 people, with more than 400,000 cases worldwide. Individuals with hemophilia suffer from spontaneous bleeding episodes as well as substantially prolonged bleeding times upon injury. In cases of severe hemophilia, spontaneous bleeding into muscles or joints is frequent and often results in permanent, disabling joint damage and can become life threatening. Treatment usually involves management of acute bleeding episodes or prophylaxis through factor replacement therapy by infusion of patients’ missing Factor VIII or IX. With the frequent infusion schedule of current therapies, adherence is difficult. In addition, convenient access to peripheral veins is often a problem, and many children require use of central venous access devices, with the concomitant risks of infection and thrombosis.

About Catalyst

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. Catalyst’s most advanced program is a potent next-generation coagulation Factor VIIa variant, marzeptacog alfa (activated), that has successfully completed an intravenous Phase 1 clinical trial in individuals with severe hemophilia A or B. Catalyst is also developing a next-generation Factor IX variant, CB 2679d/ISU304, that is IND-approved in Korea. For more information, please visit www.catalystbiosciences.com.

Back to news