-- Planned 2017 Initiation of Hemophilia B Clinical Trials Supported by Results from Preclinical Subcutaneous Dosing Studies of Next-Generation Coagulation Factors --
SOUTH SAN FRANCISCO, Calif., Feb. 14, 2017 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (Nasdaq:CBIO), a clinical-stage biopharmaceutical company focused on developing novel medicines to address hematology indications, provided an update on its clinical development plans for its next-generation Factor VIIa and Factor IX candidates and reiterated its intention to commence two clinical trials in individuals with hemophilia B in 2017.
The Company plans to initiate a subcutaneous (SQ) efficacy trial of marzeptacog alfa (activated), a next-generation Factor VIIa, in individuals with hemophilia B with inhibitors in 2017. In addition, Catalyst and its collaboration partner, ISU Abxis, plan to initiate a SQ Phase 1/2 proof-of-concept clinical trial of CB 2679d/ISU304, a next-generation coagulation Factor IX, in individuals with hemophilia B in the second quarter of 2017.
Nassim Usman, Ph.D., President and Chief Executive Officer, presented at the 19th Annual BIO CEO & Investor Conference held in New York City. A copy of Dr. Usman’s presentation slides can be found in the Investors section of the Company’s website.
About Factor VIIa
Marzeptacog alfa (activated) is a high potency next-generation Factor VIIa that successfully completed an intravenous (IV) Phase 1 clinical trial in severe hemophilia A and B patients with and without inhibitors. Marzeptacog alfa (activated) is initially being developed for the subcutaneous prophylactic treatment of severe hemophilia B patients with inhibitors. Preclinical studies of Marzeptacog alfa (activated) have demonstrated efficacy and good subcutaneous pharmacokinetic/pharmacodynamic properties in several models that support subcutaneous dosing in clinical trials.
About Factor IX
CB 2679d/ISU304 is a high potency next-generation coagulation Factor IX variant that is in advanced preclinical development. 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 and has recently shown good subcutaneous dosing properties in preclinical models. Catalyst believes that CB 2679d/ISU304 may allow for subcutaneous prophylactic treatment of individuals with hemophilia B. 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 hemophilia B. After Phase 1/2, ISU Abxis has an option for exclusive commercial rights in South Korea while Catalyst retains full development and commercial rights for CB 2679d/ISU304 outside of South Korea.
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 intravenous 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.
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 an improved 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 in advanced preclinical development. 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, future operations, and plans are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Catalyst’s clinical trial timelines and the potential uses and benefits of subcutaneously dosed marzeptacog alfa (activated) and CB 2679d/ISU304. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the 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 studies may be delayed and may not have satisfactory outcomes, that human trials will not replicate the results from animal studies, 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 that affect our ability to successfully develop, manufacture and commercialize our product candidates described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC. Catalyst does not assume any obligation to update any forward-looking statements, except as required by law.
Fletcher Payne, CFO
Catalyst Biosciences, Inc.
Red House Consulting, LLC
Catalyst Biosciences, Inc.