Catalyst Biosciences Announces Positive Factor IX Clinical Data
September 06 2017 - 8:01AM
-- CB 2679d/ISU304 is approximately 22 times more
potent than current hemophilia B therapy --
Catalyst Biosciences, Inc. (Nasdaq:CBIO), today announced positive
clinical data from the first Cohort of its ongoing Phase 1/2
proof-of-concept clinical trial in individuals with severe
hemophilia B.
Cohort 1 results (N = 3) demonstrate:
- An intravenous dose of CB 2679d is approximately 22 times more
potent than an intravenous dose of BeneFIX® as measured by activity
levels using a one-stage clotting assay; and
- The average time that CB 2679d stayed in the circulation was
significantly longer at 34 hours compared with BeneFIX at 25
hours.
These potency results, which are consistent with the Company’s
earlier research, support that CB 2679d has the potency advantage
needed to be delivered as a convenient subcutaneous prophylactic
therapy to prevent spontaneous bleeding in individuals with
Hemophilia B.
“We are excited that the higher potency and improved
pharmacokinetics of CB 2679d have been demonstrated in this
clinical trial. We believe that CB 2679d will have advantages
over the currently approved intravenous prophylactic treatments
that are known to have a prolonged period of low activity levels
with increased risk of spontaneous bleeding,” said Nassim
Usman, Ph.D., Catalyst’s President and Chief Executive Officer.
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,
document 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 cohort. 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
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 or 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 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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