Catalyst Biosciences Highlights Hemophilia Clinical Development Plans at the 19th Annual BIO CEO & Investor Conference
February 14 2017 - 8:00AM
-- Planned 2017 Initiation of Hemophilia B
Clinical Trials Supported by Results from Preclinical Subcutaneous
Dosing Studies of Next-Generation Coagulation Factors --
Catalyst Biosciences, Inc. (Nasdaq:CBIO), a clinical-stage
biopharmaceutical company focused on developing novel medicines to
address hematology indications, provided an update on its clinical
development plans for its next-generation Factor VIIa and Factor IX
candidates and reiterated its intention to commence two clinical
trials in individuals with hemophilia B in 2017.
The Company plans to initiate a subcutaneous (SQ) efficacy trial
of marzeptacog alfa (activated), a next-generation Factor VIIa, in
individuals with hemophilia B with inhibitors in 2017. In addition,
Catalyst and its collaboration partner, ISU Abxis,
plan to initiate a SQ Phase 1/2 proof-of-concept clinical
trial of CB 2679d/ISU304, a next-generation coagulation Factor IX,
in individuals with hemophilia B in the second quarter of 2017.
Nassim Usman, Ph.D., President and Chief Executive Officer,
presented at the 19th Annual BIO CEO & Investor Conference held
in New York City. A copy of Dr. Usman’s presentation slides can be
found in the Investors section of the Company’s website.
About Factor VIIaMarzeptacog alfa (activated)
is a high potency next-generation Factor VIIa that successfully
completed an intravenous (IV) Phase 1 clinical trial in severe
hemophilia A and B patients with and without inhibitors.
Marzeptacog alfa (activated) is initially being developed for the
subcutaneous prophylactic treatment of severe hemophilia B patients
with inhibitors. Preclinical studies of Marzeptacog alfa
(activated) have demonstrated efficacy and good subcutaneous
pharmacokinetic/pharmacodynamic properties in several models that
support subcutaneous dosing in clinical trials.
About Factor IX CB 2679d/ISU304 is a high
potency next-generation coagulation Factor IX variant that is in
advanced preclinical development. CB 2679d/ISU304 has exhibited
enhanced procoagulant activity, improved efficacy in inhibiting
blood loss, and prolonged duration of action in bleeding and
non-bleeding preclinical models compared with other Factor IX
products and has recently shown good subcutaneous dosing properties
in preclinical models. Catalyst believes that CB 2679d/ISU304 may
allow for subcutaneous prophylactic treatment of individuals with
hemophilia B. Catalyst has a collaboration with ISU Abxis to
advance the development of CB 2679d/ISU304 through a Phase 1/2
proof-of-concept study in individuals with hemophilia B. After
Phase 1/2, ISU Abxis has an option for exclusive commercial rights
in South Korea while Catalyst retains full development and
commercial rights for CB 2679d/ISU304 outside of South Korea.
About Hemophilia and Factor Replacement
TherapyHemophilia, 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. There are two major types of hemophilia, A and B, that
are caused by alterations in Factor VIII or Factor IX genes,
respectively, with a corresponding deficiency in the affected
proteins. The prevalence of hemophilia A and B in the United States
is estimated to be around 20,000 people, with more than 400,000
cases worldwide. Individuals with hemophilia suffer from
spontaneous bleeding episodes as well as substantially prolonged
bleeding times upon injury. In cases of severe hemophilia,
spontaneous bleeding into muscles or joints is frequent and often
results in permanent, disabling joint damage and can become life
threatening. Treatment usually involves management of acute
bleeding episodes or prophylaxis through factor replacement therapy
by intravenous infusion of patients’ missing Factor VIII or IX.
With the frequent infusion schedule of current therapies, adherence
is difficult. In addition, convenient access to peripheral veins is
often a problem, and many children require use of central venous
access devices, with the concomitant risks of infection and
thrombosis.
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. Catalyst’s most advanced program is an improved
next-generation coagulation Factor VIIa variant, marzeptacog alfa
(activated), that has successfully completed an intravenous Phase 1
clinical trial in individuals with severe hemophilia A or B.
Catalyst is also developing a next-generation Factor IX variant, CB
2679d/ISU304, that is in advanced preclinical development. For more
information, please visit www.catalystbiosciences.com
Forward-Looking Statements This 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, future operations, and plans are forward-looking
statements. Examples of such statements include, but are not
limited to, statements relating to Catalyst’s clinical trial
timelines and the potential uses and benefits of subcutaneously
dosed marzeptacog alfa (activated) and CB 2679d/ISU304. 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 from the
forward-looking statements that Catalyst makes, including, but not
limited to, the risk that trials and studies may be delayed and may
not have satisfactory outcomes, that human trials will not
replicate the results from animal studies, 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 that affect
our ability to successfully develop, manufacture and commercialize
our product candidates described in the “Risk Factors” section of
the Company’s Annual Report on Form 10-K and Quarterly Reports on
Form 10-Q filed with the SEC. Catalyst does not assume any
obligation to update any forward-looking statements, except as
required by law.
Contacts:
Investors:
Fletcher Payne, CFO
Catalyst Biosciences, Inc.
650.871.0761
investors@catbio.com
Media:
Denise Powell
Red House Consulting, LLC
510.703.9491
denise@redhousecomms.com
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