Catalyst Biosciences Announces First Patient Dosed in Marzeptacog Alfa (Activated) Phase 1/2 Study in Factor VII Deficiency, Glanzmann Thrombasthenia and Hemophilia A treated with Hemlibra
- Category: Proteins and Peptides
- Published on Tuesday, 18 May 2021 15:09
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SOUTH SAN FRANCISCO, CA, USA I May 18, 2021 I Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced the initiation of dosing in the Company's Phase 1/2 study (MAA-202) of marzeptacog alfa (activated) – known as "MarzAA." MarzAA is a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa). MAA-202 is a Phase 1/2 open-label study designed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety and efficacy of SQ MarzAA for treatment of bleeding in FVII deficiency, Glanzmann Thrombasthenia, and Hemophilia A with inhibitor patients receiving Hemlibra® prophylaxis. This study, along with Catalyst’s ongoing Phase 3 study MAA-304 evaluating MarzAA for the treatment of bleeding episodes in patients with Hemophilia A or B with inhibitors, is a key part of the Company’s strategy to realize the full potential of MarzAA to improve the lives of patients with inherited bleeding disorders.
"MarzAA is the only bypassing agent under development for the episodic treatment of bleeding events that can be rapidly administered subcutaneously and, if successful, will address a significant unmet medical need," said Nassim Usman, Ph.D., president and chief executive officer of Catalyst. "We look forward to providing updates on the MarzAA clinical development program, including reporting interim data from MAA-202 later this year."
About Catalyst Biosciences, the Protease Medicines company
Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare disorders of the complement and coagulation systems. Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, an SQ administered next-generation engineered rFVIIa for the episodic treatment of bleeding in subjects with rare bleeding disorders. Our complement pipeline includes a preclinical C3-degrader program licensed to Biogen for dry age-related macular degeneration, an improved complement factor I protease for SQ replacement therapy in patients with CFI deficiency, and C4b-degraders designed to target disorders of the classical complement pathway, as well as other complement programs in discovery.
SOURCE: Catalyst Biosciences