— Factor IX oral presentation & Factor VIIa poster presentation —
— Presentations to summarize the pharmacokinetics and activity of daily subcutaneous dosing in preclinical hemophilia models —
SOUTH SAN FRANCISCO, Calif., June 08, 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 data from two of its product candidates will be presented at the International Society on Thrombosis and Haemostasis (ISTH) Meeting being held in Berlin, Germany from July 8 to 13, 2017.
Catalyst is focused on the prevention of bleeding in individuals with hemophilia through the development of clotting factors that may be injected subcutaneously, rather than intravenously, potentially achieving normal coagulation activity.
Catalyst recently announced that CB 2679d/ISU304, its next-generation Factor IX variant, received a positive Orphan Drug Designation recommendation in the EU. Catalyst’s South Korean collaborator, ISU Abxis, plans to initiate a Phase 1/2 proof-of-concept study of CB 2679d in individuals with severe hemophilia B in June 2017 in South Korea.
The presentations being made by Catalyst are as follows:
Factor IX: CB 2679d/ISU304 is a next-generation coagulation Factor IX variant that is IND-approved in South Korea.
|Title||Pharmacokinetic and Activity Levels Achieved with Daily Subcutaneously Administered CB 2679d/ISU304 in Hemophilia B Dogs|
|Presenter||Howard Levy, M.B.B.Ch., Ph.D., M.M.M.|
|Session||Future Biotherapeutics for Hemophilia A and B
Monday, July 10, 2017 at 10:00 am CET
Factor VIIa: Marzeptacog alfa (activated) is a next-generation Factor VIIa that successfully completed an intravenous Phase 1 clinical trial in severe hemophilia A and B with and without inhibitors. Catalyst plans to initiate a subcutaneous dosing efficacy study of marzeptacog alfa (activated) in individuals with hemophilia B with inhibitors in 2017.
|Title:||Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered|
|Marzeptacog Alfa (Activated) in Hemophilia B Mice, Levy et al.|
|Tuesday, July 11, 2017 from 12:00-13:15 pm CET|
About Factor IX
CB 2679d/ISU304 is a next-generation coagulation Factor IX variant that is IND-approved 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.
About Factor VIIa
Marzeptacog alfa (activated) is a high potency next-generation Factor VIIa that is initially being developed for the subcutaneous prophylactic treatment of severe hemophilia A and B patients with inhibitors. Learn more about Factor VIIa.
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, 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, including the 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 June 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.
CONTACT: Contacts: Investors: Fletcher Payne, CFO Catalyst Biosciences, Inc. 650.871.0761 [email protected] Media: Denise Powell Red House Consulting, LLC 510.703.9491 [email protected]