Catalyst Biosciences Announces Updated Positive Interim Data at the 2018 Hemophilia Drug Development Summit
August 15 2018 - 8:00AM
Data demonstrates continued efficacy of marzeptacog
alfa (activated) in two additional subjects
Catalyst Biosciences, Inc. (NASDAQ:CBIO), a clinical-stage
biopharmaceutical company focused on developing novel medicines to
address hematology indications, today announced updated positive
interim data from its Phase 2/3 study of subcutaneous (SQ)
prophylactic Factor VIIa (FVIIa) variant marzeptacog alfa
(activated) (MarzAA), being developed for the treatment of
hemophilia A or B with inhibitors. The data will be delivered in an
oral presentation today at the 2018 Hemophilia Drug Development
Summit being held on August 15-16 in Boston.
“The ongoing study of subcutaneous MarzAA for
the treatment of hemophilia A or B with inhibitors continues to
demonstrate positive interim results, as reflected in the clinical
update provided at this year’s Hemophilia Drug Development Summit,”
said Nassim Usman, Ph.D., chief executive officer of Catalyst. “We
have not observed any bleeds or anti-drug antibodies in the two
additional subjects who most recently completed dosing with 30
µg/kg MarzAA, as well as in the previously reported individual who
completed 50 days of dosing with 60 µg/kg MarzAA. The data from
these three individuals support the efficacy of MarzAA to reduce
annualized bleed rates after daily subcutaneous injections.
Importantly, to date we have not observed any injection site
reactions nor any anti-drug antibodies after more than 200
subcutaneous doses of MarzAA.”
Dr. Howard Levy, chief medical officer of
Catalyst, will present the updated interim results from the MarzAA
Phase 2/3 trial in which five of up to 12 subjects have been
enrolled. Since initial interim data was announced at the ISTH
conference in July 2018, in which one subject with a historic
annualized bleed rate (ABR) of 26.7 had completed the trial with no
bleeds after 50 days of treatment with 60 µg/kg MarzAA, two
additional subjects have now completed the trial. One of these
subjects, who has a historic ABR of 16.6, had no bleeds during
treatment with 30 µg/kg MarzAA for 50 days. No ADAs have been
detected to date, with safety data for the final 10 days of dosing
still being collected for this subject. The second subject, who has
a historic ABR of 15.9, had no bleeds during treatment with 30
µg/kg MarzAA for 44 days. No ADAs have been detected to date.
A copy of the presentation materials can be
accessed on the Events and Presentations section of the Catalyst
website once the presentation concludes.
About the FVIIa Phase 2/3
TrialMarzeptacog alfa (activated) (MarzAA) is a potent,
subcutaneous Factor VIIa therapy being developed for prophylaxis in
hemophilia A or B with inhibitors. The Phase 2/3 open-label,
subcutaneous efficacy trial in individuals with hemophilia A or B
with inhibitors will evaluate the ability of MarzAA to eliminate,
or minimize, spontaneous bleeding episodes. The primary endpoint is
a reduction in annualized bleed rate that will be compared with
each individual’s recorded historical annualized bleed rate as the
control. The trial will enroll up to 12 individuals with hemophilia
and an inhibitor across approximately ten clinical trial sites
globally. MarzAA has been granted orphan drug designation by the
U.S. Food and Drug Administration (FDA) for routine prophylaxis to
prevent bleeding episodes in individuals with hemophilia A or B
with inhibitors.
About Catalyst Biosciences,
Inc.Catalyst 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. Forward-looking statements include statements
about the potential for marzeptacog alfa (activated) (MarzAA) to
provide prophylaxis therapy in patients with hemophilia A or B with
inhibitors, Catalyst’s plans to complete a Phase 2/3 open label
trial of this product candidate, and Catalyst’s plans to continue
development of this and other product candidates. 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 the Company makes, including, but not limited to, the risk
that trials and studies may be delayed and may not have
satisfactory outcomes, that additional human trials will not
replicate the results from earlier trials, including interim data,
that potential adverse effects may arise from the testing or use of
MarzAA or other Catalyst product candidates, 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 Quarterly Report on Form 10-Q for the quarter ended June
30, 2018 filed with the Securities and Exchange Commission on
August 2, 2018, and with 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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