Catalyst Biosciences Announces First Patient Dosed in Marzeptacog Alfa (Activated) Phase 1/2 Study in Factor VII Deficiency, ...
May 18 2021 - 8:00AM
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 companyCatalyst 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.
Forward-Looking Statements This
press release contains forward-looking statements that involve
substantial risks and uncertainties. Forward-looking statements
include statements about the potential benefits of products based
on Catalyst's engineered protease platform, and plans to conduct
the MAA-202 and MAA-304 clinical trials of MarzAA. 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 the one or both of the clinical trials of MarzAA may be
delayed or terminated as a result of COVID-19, competitive products
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 trial enrollment, development and
manufacturing resulting from COVID-19 and other factors,
competition and other risks described in the "Risk Factors" section
of the Company's Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission on May 6,
2021, 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 KaporCatalyst Biosciences, Inc.investors@catbio.com
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