-- First successful dosing of a subcutaneous Factor IX in a clinical trial --
SOUTH SAN FRANCISCO, Calif., Sept. 25, 2017 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (Nasdaq:CBIO), today announced that its collaborator ISU Abxis has completed dosing of the first subcutaneous cohort (N = 3, the second of up to five patient cohorts) in an ongoing Phase 1/2 proof-of-concept clinical trial in individuals with severe hemophilia B. The companies plan to have interim top-line data from the trial by the end of 2017.
The clinical trial includes single intravenous and subcutaneous dosing cohorts, followed by daily subcutaneous injections of CB 2679d/ISU304, Catalyst’s highly potent next-generation coagulation Factor IX variant.
“The positive results that we reported earlier this month from Cohort 1 (N = 3) demonstrated the drug potency and circulation profile that we believe will support subcutaneous prophylaxis and may normalize Factor IX levels. Results from the Phase 1/2 trial will be reported at upcoming medical conferences,” said Nassim Usman, Ph.D., Catalyst’s President and Chief Executive Officer. “Currently approved hemophilia B therapies require frequent intravenous infusions and do not result in sustained normalization of Factor IX activity – we aim to change this treatment paradigm.”
About the Ongoing Clinical Trial
The clinical trial is being conducted at three centers in South Korea by the Company’s collaborator, ISU Abxis, which uses ISU304 as an alternate product name. The trial will, among other things, measure the subcutaneous bioavailability and clotting ability of CB 2679d achieved with single intravenous and subcutaneous dosing cohorts, followed by daily subcutaneous injections of CB 2679d in the fifth, and final, cohort. Earlier this month, the Company announced positive results from the first Cohort of the clinical trial demonstrating that an intravenous dose of CB 2679d is approximately 22 times more potent than an intravenous dose of BeneFIX® and that the average time that CB 2679d stayed in the circulation was significantly longer compared to BeneFIX (34 hours vs 25 hours). Interim, top-line results of this open-label study are expected by the end of 2017 and complete trial results in early 2018.
About Factor IX
CB 2679d is a next-generation high-potency 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 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. 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, please visit www.catalystbiosciences.com.
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statement of historical facts, included in this press release regarding our strategy, the potential uses and benefits of CB 2679d and development plans for this product candidate are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Catalyst’s clinical trial timelines, including the anticipated completion of a Phase 1/2 proof-of-concept study for CB 2679d, the plans to disclose interim top-line results from the Phase 1/2 study by the end of 2017 and complete trial results by early 2018 and to report results at upcoming medical conferences, and the potential uses and benefits of subcutaneously dosed CB 2679d. Actual results or events could differ materially from the plans and expectations and projections disclosed in these forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Catalyst makes, including, but not limited to, the risk that trials and enrollment may be delayed and may not have satisfactory outcomes, that human trials will not replicate the results from preclinical studies, that subcutaneous dosing of CB 2679d may not replicate potency or duration of blood levels, that potential adverse effects may arise from the testing or use of Catalyst’s products, including the generation of antibodies, the risk that costs required to develop or manufacture Catalyst’s products will be higher than anticipated, competition, and other factors described in the “Risk Factors” section of the Company’s most recent Quarterly Report on Form 10-Q filed with the SEC on August 3, 2017. Catalyst does not assume any obligation to update any forward-looking statements, except as required by law.
Fletcher Payne, CFO, Catalyst Biosciences
Catalyst Biosciences, Inc.