Catalyst Biosciences Provides DalcA Phase 2b Trial Update
October 03 2019 - 8:00AM
Catalyst Biosciences, Inc. (NASDAQ: CBIO), today provided an update
on enrollment in its Phase 2b study of dalcinonacog alfa (DalcA), a
next-generation subcutaneously (SQ) administered Factor IX (FIX)
therapy being developed for the treatment of hemophilia B. Two
subjects have completed dosing and washout, Factor IX levels in
these two subjects exceeded the trial efficacy endpoint of >12%
activity and no anti-drug antibodies were detected. Enrollment is
ongoing and the Company anticipates reporting final data in the
first half of 2020.
“We believe that DalcA may offer a
conveniently-dosed subcutaneous prophylactic treatment option that
could significantly improve the quality of life for those suffering
from severe hemophilia B,” said Nassim Usman, Ph.D., president and
chief executive officer of Catalyst. “We are very pleased with the
FIX activity and lack of ADAs obtained and look forward to
providing final data in the first half of 2020.”
The open-label Phase 2b study is evaluating the
ability of DalcA to maintain steady state FIX levels above 12% in
individuals with severe hemophilia B. The trial is expected to
enroll up to six completing subjects who will receive a single
intravenous dose, followed by daily subcutaneous (SQ) doses of
DalcA for 28 days. Pharmacokinetics, pharmacodynamics, safety and
tolerability of daily SQ dosing and anti-drug antibody formation
are being monitored. The trial is actively enrolling and study
participants have been identified.
Nassim Usman, Ph.D., president and chief
executive officer of Catalyst Biosciences, is presenting a
corporate overview at the Cantor 2019 Global Healthcare Conference
at 8:20 a.m. ET today, October 3, 2019, in New York. To access a
live webcast of the presentation, please
visit http://wsw.com/webcast/cantor10/cbio/. An archived
webcast of the presentation will be available for 90 days on the
Events and Presentations section on the Company’s website.
About Catalyst
BiosciencesCatalyst is a clinical-stage biopharmaceutical
company developing novel medicines to address hematology
indications. Catalyst has engineered a portfolio of compounds that
have increased potency over the naturally occurring proteases.
Catalyst is focused on the field of hemostasis, including the
subcutaneous treatment of hemophilia and facilitating surgery in
individuals with hemophilia. For more information, please visit
www.catalystbiosciences.com.
Forward-Looking Statements This
press release may contain forward-looking statements that involve
substantial risks and uncertainties. Forward-looking statements
include statements about the potential uses and benefits of
Catalyst’s products in development to address hemophilia
indications, statements about Catalyst’s clinical trial plans for
DalcA, the timing of the clinical trial, anticipated
reporting of data in the first half of 2020, and the potential for
the DalcA 2b trial to meet its endpoints. 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, 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, that potential adverse effects may
arise from the testing or use of DalcA or MarzAA, including the
generation of antibodies, which has been observed in patients
previously treated with DalcA, the risk that costs required to
develop or manufacture the Company’s products will be higher than
anticipated, competition and other factors that affect the
Company’s ability to establish collaborations on commercially
reasonable terms and other risks described in the “Risk Factors”
section of the Company’s annual report filed with
the Securities and Exchange Commission on March 8,
2019, and in 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:Ana Kapor
Catalyst Biosciences, Inc. 1.650.266.7144investors@catbio.com
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