Catalyst Biosciences Announces First Patient Dosed in Pivotal Phase 3 Registration Study of SQ MarzAA in Individuals with Hem...
05 May 2021 - 10:00PM
Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced the
dosing of the first patient in the Crimson 1 Study, the Company's
Phase 3 registration trial (MAA-304 - Crimson 1) of Marzeptacog
alfa (activated) – or MarzAA, the Company's subcutaneously (SQ)
administered next-generation engineered recombinant coagulation
Factor VIIa (rFVIIa).
"Dosing the first patient in our pivotal Phase 3
study of MarzAA is an important milestone for Catalyst given the
significant challenges encountered in conducting clinical trials
during the ongoing global Covid-19 pandemic,” said Nassim Usman,
Ph.D., president and chief executive officer of Catalyst. “MarzAA
is the only SQ-delivered therapy in development for the episodic
treatment of bleeding events and if successful, could fundamentally
change patients’ lives. We look forward to providing further
updates on the MAA-304 study, the associated Phase 1/2 study
(MAA-202) in other rare bleeding disorders, and in our growing
complement pipeline later this year."
Crimson 1 is an open-label, global,
multi-center, randomized, cross-over study, designed to evaluate
the safety and efficacy of SQ MarzAA for episodic treatment of
spontaneous or traumatic bleeding episodes, in adults and
adolescents with congenital Hemophilia A or B with inhibitors,
compared with standard of care. The study will assess the
effectiveness of SQ MarzAA, using up to three doses to treat a
bleeding episode, compared with IV FEIBA or up to three doses of IV
rFVIIa. Catalyst anticipates the submission of its first report to
the Data and Safety Monitoring Board (DSMB) in 2021.
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, plans to enroll the
Phase 3 open-label trial of MarzAA, and plans to submit the first
report to the Data and Safety Monitoring Board (DSMB) in 2021.
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 Phase 3 trial of MarzAA and other
trials may be delayed or terminated as a result of COVID-19,
competitive products and other factors, that Catalyst may not
submit its first report to the DSMB as planned, 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 Annual Report on Form 10-K
filed with the Securities and Exchange
Commission on March 4, 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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