Financial Milestone Achieved in Catalyst’s Subcutaneous Factor IX Program

Catalyst Biosciences, Inc. recently announced it has achieved a financial milestone under its collaboration with ISU Abxis. In June 2017, the first patient and cohort were enrolled in a Phase 1/2 proof-of-concept clinical trial in individuals with severe hemophilia B, which triggered the milestone payment to Catalyst. The clinical trial will evaluate Catalyst’s next-generation Factor IX variant, CB 2679d/ISU304, for subcutaneous prophylaxis. ISU Abxis and Catalyst plan to have top-line data from the clinical trial by the end of 2017.

As previously announced, ISU Abxis has completed dosing of the first cohort of up to five patient cohorts in the clinical trial. The trial will include single intravenous and subcutaneous dosing cohorts, followed by daily subcutaneous injections of CB 2679d/ISU304.

“We are pleased to have achieved another financial milestone with the Factor IX clinical program, but for us the highlight of the Factor IX program has been the rapid patient enrollment in the clinical trial to date,” said Nassim Usman, PhD, President and Chief Executive Officer of Catalyst. “We want to prevent bleeding in individuals with hemophilia B and we look forward to results later this year that may determine whether CB 2679d/ISU304 can achieve sustained normalization of Factor IX activity with subcutaneous dosing.”

Catalyst has a collaboration with ISU Abxis to advance the development of CB 2679d/ISU304 through the Phase 1/2 proof-of-concept clinical trial in individuals with 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.

CB 2679d/ISU304 is a next-generation coagulation Factor IX variant that is being evaluated in a Phase 1/2 proof-of-concept clinical trial 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.