Catalyst Biosciences Announces Poster Presentation at the 62nd Annual American Society of Hematology Conference
Catalyst Biosciences, Inc. (NASDAQ: CBIO) announced a poster presentation on Marzeptacog alfa (activated) or MarzAA at the 62nd Annual American Society of Hematology meeting, scheduled for December 5-8, 2020. The presentation will cover the Phase 3 Crimson 1 Study, which evaluates MarzAA for treating bleeding episodes in patients with Hemophilia A and B with inhibitors. The first patient is set to be dosed by late 2020. MarzAA represents the only subcutaneous bypass agent in development for these conditions. Catalyst focuses on rare hematologic disorders, with multiple clinical programs underway.
- MarzAA is the only subcutaneously administered bypass agent in development for Hemophilia A and B with inhibitors.
- The Phase 3 Crimson 1 study aims to treat episodic bleeding in patients, indicating significant market potential.
- First patient dosing is planned by late 2020, advancing the development timeline for MarzAA.
- Forward-looking statements include risks related to clinical trial delays, adverse effects, and potential higher development costs due to COVID-19.
- There are uncertainties regarding the trial outcomes and the possibility of failing to replicate previous results.
SOUTH SAN FRANCISCO, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced a trials in progress poster presentation on Marzeptacog alfa (activated) – or MarzAA, the Company’s subcutaneously administered next-generation engineered coagulation Factor VIIa (FVIIa), at the upcoming 62nd Annual American Society of Hematology (ASH) meeting being held virtually December 5-8, 2020.
| Poster presentation details: | |
| Poster Title: | The Crimson 1 Study: A Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous Marzeptacog Alfa (activated) for on-Demand Treatment and Control of Bleeding Episodes in Subjects with Hemophilia A or Hemophilia B, with Inhibitors |
| Presenting Author: | Linda Neuman, M.D., M.B.A., vice president, clinical development, Catalyst Biosciences |
| Date/Time: | Sunday, December 6, 2020 / 7 am PT |
A copy of the presentation materials can be accessed on the Events and Presentations section of the Catalyst website on the day of the presentation.
MarzAA, a next-generation recombinant Factor VIIa variant, is the only subcutaneously administered bypass agent in development for the treatment of Hemophilia A or B with inhibitors and other rare bleeding disorders, including Factor VII Deficiency and Glanzmann thrombasthenia. In late 2020, Catalyst Biosciences plans to dose the first patient in Crimson 1, its Phase 3 study of MarzAA for treatment of episodic bleeding in Hemophilia A and B with inhibitors.
About Catalyst Biosciences
Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare hematologic and complement-mediated disorders. Our protease engineering platform generated two late-stage clinical programs in hemophilia; a research program on engineering of subcutaneous (SQ) complement inhibitors; a discovery stage Factor IX gene therapy construct - CB 2679d-GT - for Hemophilia B, and a partnered preclinical development program with Biogen for dry age-related macular degeneration (AMD). The product candidates generated by our protease engineering platform have improved functionality and potency that allow for: SQ administration of recombinant coagulation factors and complement inhibitors; low-dose, high activity gene therapy constructs; and less frequently dosed intravitreal therapeutics.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements about Catalyst’s plans to enroll the first patient in a Phase 3 open-label trial of MarzAA and initiate a Phase 1/2 trial of MarzAA in FVII Deficiency, Glanzmann Thrombasthenia, and Hemlibra patients before year-end, the potential for MarzAA to effectively and therapeutically treat hemophilia subcutaneously, the superiority of CB 2679d-GT over other gene therapy candidates and the Company’s collaboration with Biogen for the development and commercialization of pegylated CB 2782 for the potential treatment of geographic atrophy-associated dry age-related macular degeneration. 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, including, but not limited to, the risk that trials and studies may be delayed as a result of COVID-19 and other factors, that trials may not have satisfactory outcomes, that additional human trials will not replicate the results from earlier trials, that potential adverse effects may arise from the testing or use of MarzAA, including the generation of neutralizing antibodies, the risk that costs required to develop or manufacture the Company’s products will be higher than anticipated, including as a result of delays in development and manufacturing resulting from COVID-19 and other factors, the risk that Biogen will terminate Catalyst’s agreement, competition and other risks described in the “Risk Factors” section of the Company’s quarterly report filed with the Securities and Exchange Commission on November 5, 2020, and in other filings with the Securities and Exchange Commission. The Company does not assume any obligation to update any forward-looking statements, except as required by law.
Contact:
Ana Kapor
Catalyst Biosciences, Inc.
investors@catbio.com
FAQ
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