Catalyst Biosciences Announces Successful Completion of First Subcutaneous Dosing Cohort in Ongoing Hemophilia B Clinical Tri...
25 September 2017 - 10:01PM
Catalyst Biosciences, Inc. (Nasdaq:CBIO), today announced
that its collaborator ISU Abxis has completed dosing of
the first subcutaneous cohort (N = 3, the second of up to five
patient cohorts) in an ongoing Phase 1/2 proof-of-concept clinical
trial in individuals with severe hemophilia B. The companies plan
to have interim top-line data from the trial by the end of 2017.
The clinical trial includes single intravenous and subcutaneous
dosing cohorts, followed by daily subcutaneous injections of CB
2679d/ISU304, Catalyst’s highly potent next-generation coagulation
Factor IX variant.
“The positive results that we reported earlier this month from
Cohort 1 (N = 3) demonstrated the drug potency and circulation
profile that we believe will support subcutaneous prophylaxis and
may normalize Factor IX levels. Results from the Phase 1/2 trial
will be reported at upcoming medical conferences,” said Nassim
Usman, Ph.D., Catalyst’s President and Chief Executive Officer.
“Currently approved hemophilia B therapies require frequent
intravenous infusions and do not result in sustained normalization
of Factor IX activity – we aim to change this treatment
paradigm.”
About the Ongoing Clinical TrialThe clinical
trial is being conducted at three centers in South Korea by the
Company’s collaborator, ISU Abxis, which uses ISU304 as an
alternate product name. The trial will, among other
things, measure the subcutaneous bioavailability and clotting
ability of CB 2679d achieved with single intravenous and
subcutaneous dosing cohorts, followed by daily subcutaneous
injections of CB 2679d in the fifth, and final, cohort. Earlier
this month, the Company announced positive results from the first
Cohort of the clinical trial demonstrating that an intravenous dose
of CB 2679d is approximately 22 times more potent than an
intravenous dose of BeneFIX® and that the average time that CB
2679d stayed in the circulation was significantly longer compared
to BeneFIX (34 hours vs 25 hours). Interim, top-line results of
this open-label study are expected by the end of 2017 and complete
trial results in early 2018.
About Factor IX CB 2679d is a next-generation
high-potency coagulation Factor IX variant that is being evaluated
in a Phase 1/2 proof-of-concept clinical trial in South Korea.
Catalyst believes that CB 2679d may allow for subcutaneous
prophylactic treatment of individuals with hemophilia B.
About Hemophilia and Factor Replacement Therapy
Hemophilia, for which there is no cure, is a rare but serious
bleeding disorder that results from a genetic or an acquired
deficiency of a protein required for normal blood coagulation.
Individuals with hemophilia suffer from spontaneous bleeding
episodes as well as substantially prolonged bleeding times upon
injury. Learn more about hemophilia.
About Catalyst Catalyst is a clinical-stage
biopharmaceutical company focused on developing novel medicines to
address hematology indications. Catalyst is focused on the field of
hemostasis, including the subcutaneous prophylaxis of hemophilia
and facilitating surgery in individuals with hemophilia. For more
information, please visit www.catalystbiosciences.com.
Forward-Looking StatementsThis press release
contains forward-looking statements that involve substantial risks
and uncertainties. All statements, other than statement of
historical facts, included in this press release regarding our
strategy, the potential uses and benefits of CB 2679d and
development plans for this product candidate are forward-looking
statements. Examples of such statements include, but are not
limited to, statements relating to Catalyst’s clinical trial
timelines, including the anticipated completion of a Phase 1/2
proof-of-concept study for CB 2679d, the plans to disclose interim
top-line results from the Phase 1/2 study by the end of 2017 and
complete trial results by early 2018 and to report results at
upcoming medical conferences, and the potential uses and benefits
of subcutaneously dosed CB 2679d. Actual results or events could
differ materially from the plans and expectations and projections
disclosed in these forward-looking statements. Various important
factors could cause actual results or events to differ materially
from the forward-looking statements that Catalyst makes, including,
but not limited to, the risk that trials and enrollment may be
delayed and may not have satisfactory outcomes, that human trials
will not replicate the results from preclinical studies, that
subcutaneous dosing of CB 2679d may not replicate potency or
duration of blood levels, that potential adverse effects may arise
from the testing or use of Catalyst’s products, including the
generation of antibodies, the risk that costs required to develop
or manufacture Catalyst’s products will be higher than anticipated,
competition, and other factors described in the “Risk Factors”
section of the Company’s most recent Quarterly Report on Form 10-Q
filed with the SEC on August 3, 2017. Catalyst does not assume
any obligation to update any forward-looking statements, except as
required by law.
Contacts:
Investors:
Fletcher Payne, CFO, Catalyst Biosciences
650.871.0761
investors@catbio.com
Media:
Denise Powell
510.703.9491
denise@redhousecomms.com
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