SOUTH SAN FRANCISCO, Calif., Jan. 26, 2017 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc., a clinical-stage biopharmaceutical company focused on developing novel medicines to address hematology indications, today announced that data from two of its investigational coagulation factors will be presented at the 10th Annual Congress of the European Association of Haemophilia and Allied Disorders (EAHAD) being held in Paris, France from February 1 to 3, 2017. The poster presentations, by Catalyst and its collaborators, will be available for viewing throughout the conference.
Catalyst is focused on the prevention of bleeding in individuals with hemophilia through the development of clotting factors that may be injected subcutaneously to potentially achieve normal coagulation activity.
Factor VIIa: Marzeptacog alfa (activated) is a next-generation Factor VIIa that successfully completed a Phase 1 clinical trial in severe hemophilia A and B with and without inhibitors. Catalyst plans to initiate an efficacy study of marzeptacog alfa (activated) in individuals with hemophilia B with inhibitors in 2017.
Poster P076: Pharmacokinetics And Pharmacodynamics Of Daily Subcutaneously Administered Marzeptacog Alfa (Activated) In Hemophilia Dogs, Levy et al.
Factor IX: CB 2679d/ISU304 is a next-generation coagulation Factor IX variant that is in advanced preclinical development. Catalyst plans to initiate a Phase 1/2 proof-of-concept study of CB 2679d in individuals with hemophilia B in the first quarter of 2017.
Poster P074: Pharmacokinetics Of Subcutaneously Administered CB 2679d/ISU304 In Minipig Compared With Benefix, Hong et al.
Poster P075: Pharmacokinetics And Pharmacodynamics Of Daily Subcutaneously Administered CB 2679d/ISU304 In Hemophilia B Dogs, Levy et al.
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 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.catbio.com.
Forward-Looking Statements
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, including the anticipated benefits of the Wyeth and CBC Biologics agreements, the anticipated initiation of an efficacy study for marzeptacog alfa (activated) in 2017 and of a Phase 1/2 clinical trial for Factor IX CB 2679d/ISU304 in the first quarter of 2017, 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.