Catalyst Biosciences Announces First Patient Screened for CFI deficiency in its CB 4332 Screening and Natural History of Disease Studies
July 22 2021 - 8:00AM
Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced the
screening of the first patient in its CFI-deficiency study in the
CB 4332 program, its wholly-owned, first-in-class, enhanced
Complement Factor I (CFI), intended for prophylactic subcutaneous
(SQ) administration in individuals with CFI deficiency.
"The findings from the CFI deficiency screening and natural
history of disease studies will be instrumental in identifying
patients for the Phase 1/2 trial of CB 4332, planned for mid-year
2022,” said Nassim Usman, Ph.D., president and chief executive
officer of Catalyst. “Following the disease manifestations and
biomarkers of this complement disorder will be important in
unlocking the full therapeutic potential of CB 4332.”
The ConFIrm screening study
will measure CFI levels and activity in patients who have diseases
related to a CFI deficiency and who may potentially benefit from CB
4332 treatment. The ConFIdence
natural history of disease study will follow these CFI-deficient
subjects, who often present with repetitive bacterial infections,
immune-related diseases, and/or glomerulopathies, for clinical
biomarkers and safety of current treatments. The findings from
these studies will identify opportunities to potentially develop CB
4332 for treatment in multiple indications.
Catalyst’s complement portfolio is led by the
development candidates CB 4332 and CB 2782-PEG, originating from
the company’s internal discovery platform, which has generated a
rich pipeline of leads. CB 4332 is an engineered CFI protease with
the potential to address multiple complement related disorders. CB
2782-PEG is designed as a long-acting anti-C3 protease in
preclinical development for the treatment of dry AMD that Catalyst
has licensed to Biogen. Catalyst has several engineered protease
programs in discovery or early non-clinical development. These
programs all target diseases caused by deficient regulation of the
complement system.
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, a subcutaneously
(SQ) administered next-generation engineered coagulation Factor
VIIa (FVIIa) for the treatment of episodic 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 proteases from our ProTUNE™ C3b-C4b degrader and ImmunoTUNE™
C3a-C5a degrader platforms designed to target specific disorders of
the complement or inflammatory pathways as well as other complement
programs in development.
Forward-Looking StatementsThis
press release contains forward-looking statements that involve
substantial risks and uncertainties. Forward-looking
statements include, without limitation, statements about the
product candidates of Catalyst Biosciences, Inc. (the “Company”)
and the benefits of its protease engineering platform; plans to
complete the ConFIrm and
ConFIdence studies and the
expectation that the studies will inform opportunities to develop
CB 4332; the potential markets for and advantages of the Company's
complement product candidates, including CB 2782-PEG, CB 4332 and
complement degraders; plans for the Company's collaboration with
Biogen; and plans to conduct for a Phase 1/2 clinical trial of CB
4332 in 2022.
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, competitive products and other factors, that
trials may not have satisfactory outcomes, 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, the risk that Biogen will terminate Catalyst's
agreement, 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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