Catalyst Biosciences Announces Korean Ministry of Food and Drug Safety Approves Addition of Sixth Cohort to the Phase 1/2 Tri...
April 12 2018 - 8:00AM
Initiation of Phase 2b Trial on Track for Q3
2018
Catalyst Biosciences, Inc. (Nasdaq:CBIO), a clinical-stage
biopharmaceutical company focused on developing novel medicines to
address hematology indications, today announced that the Korean
Ministry of Food and Drug Safety (MFDS) approved the addition of a
sixth cohort to the Phase 1/2 trial of CB 2679d in individuals with
severe hemophilia B following positive data from the multi-dose
Cohort 5 that was disclosed on February 9.
Cohort 6 will enroll up to five patients. Each individual will
receive a single intravenous loading dose of 75 IU/kg, followed by
nine daily subcutaneous doses of 150 IU/kg CB 2679d. The loading
dose will be administered 30 minutes before the first subcutaneous
dose. The study will be completed in South Korea in coordination
with the Company’s collaborator ISU Abxis.
“The addition of this sixth cohort will allow us to build on the
progressive increase in Factor IX activity levels, from severe to
mild hemophilia, that we observed after six daily subcutaneous
doses in Cohort 5 of this Phase 1/2 trial,” said Nassim Usman,
Ph.D., chief executive officer of Catalyst. “The Cohort 6 design
will also allow us to evaluate the benefits of a single IV loading
dose of CB 2679d. Interim results from this sixth cohort are
expected in Q3 2018 with additional data in Q4 2018. Data from this
cohort will inform the design of future trials, including the
upcoming Phase 2b trial, planned to begin in Q3 2018.”
About the FIX Phase 1/2 TrialCB
2679d is designed as a best-in-class high potency recombinant
Factor IX product. The Phase 1/2 clinical trial of CB 2679d in
patients with severe hemophilia B 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 measures
the potency, subcutaneous bioavailability, half-life and clotting
ability of CB 2679d achieved after single intravenous and
subcutaneous dosing in the first three cohorts, and daily
subcutaneous injections of CB 2679d with and without an intravenous
loading dose in the fifth cohort and sixth cohorts, respectively.
Catalyst believes that CB 2679d may provide a subcutaneous
prophylactic treatment for individuals with hemophilia B by
achieving high-mild hemophilia FIX activity levels in blood. CB
2679d was awarded orphan drug designations by the European
Commission in June 2017 and by the U.S. Food and Drug
Administration (FDA) in September 2017.
About CatalystCatalyst is a clinical-stage
biopharmaceutical company 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 fact, 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, the potential for subcutaneous dosing of
CB2679d to maintain clotting activity in the high-mild hemophilia
range, plans for the commencement of a Phase 2b clinical trial of
CB 2679d, and the anticipated results of Cohort 6 are
forward-looking statements. Actual results or events could differ
materially from the plans, intentions, expectations and projections
disclosed in the forward-looking statements as a result of various
important factors, including, but not limited to, the risk that
trials and studies may be delayed and may not have satisfactory
outcomes, that Cohort 6 will not replicate the results from earlier
human trials (including Cohort 5) or from prior animal studies,
that potential adverse effects may arise from the testing or use of
the Company’s products, including the generation of antibodies, the
risk that costs required to develop or manufacture the Company’s
products will be higher than anticipated, competition and other
factors that affect our ability to establish collaborations on
commercially reasonable terms and other risks described in the
“Risk Factors” section of the Company’s Annual Report on Form 10-K
for the year ended December 31, 2017, filed with the Securities and
Exchange Commission on March 19, 2018, along with our 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.
Contacts
Investors:Fletcher Payne, CFOCatalyst
Biosciences, Inc.+1.650.871.0761investors@catbio.com
Media:Josephine Belluardo, Ph.D.LifeSci Public
Relations+1.646.751.4361jo@lifescipublicrelations.com
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