Catalyst Biosciences Announces Interim Phase 1/2 CB 2679d/ISU304 Results at the American Society of Hematology Conference
December 09 2017 - 9:30AM
Subcutaneous (SQ) delivery significantly
increases half-life of CB 2679d to 98.7 hours
Catalyst Biosciences, Inc. (NASDAQ:CBIO), a clinical-stage
biopharmaceutical company focused on developing novel medicines to
address hematology indications, today announced interim Phase 1/2
data on its subcutaneously administered, prophylactic Factor IX
variant CB 2679d/ISU304 in an oral presentation at the 59th
American Society of Hematology (ASH) Annual Meeting and Exposition
held on Dec. 9-12, 2017 in Atlanta. The data demonstrate that
subcutaneous delivery of CB 2679d significantly increases the
factor IX (FIX) activity half-life to 98.7 hours.
Dr. Howard Levy, chief medical officer of
Catalyst, presented results from the first three cohorts of the
Phase 1/2 trial of CB 2679d in patients with severe hemophilia B.
During these first three cohorts, patients received single
intravenous (IV) and subcutaneous (SQ) doses of CB 2679d. Results
from cohort 1, which compared 75 IU/kg IV CB 2679d to 75 IU/kg IV
BeneFIX, showed that IV CB 2679d is approximately 22 times more
potent and has a significantly longer half-life and mean residence
time than BeneFIX (36 hours vs. 25 hours). Cohorts 2 and 3 compared
75 IU/kg IV CB 2679d to 75 IU/kg and 150 IU/kg SQ CB 2679d
respectively. These results showed that SQ delivery of CB 2679d had
a bioavailability of 18.5% and significantly increases the FIX
activity half-life to 98.7 hours. No serious adverse events were
observed. The data to date support the potential of achieving
normal FIX levels in individuals with hemophilia B with daily or
less frequent subcutaneous dosing.
“The results from these first three cohorts
demonstrate the promise of CB 2679d as a safe prophylactic
treatment for patients with hemophilia B,” said Dr. Levy. “The
significantly increased half-life of CB 2679d and bioavailability
after subcutaneous dosing suggests that CB 2679d may provide
superior prophylaxis capabilities compared with intravenous
extended half-life agents, with the potential to normalize FIX
levels. We eagerly await the results from daily subcutaneous doses
of CB 2679d on Factor IX blood levels that are expected in early
2018.”
About the 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 aims to measure the subcutaneous
bioavailability and clotting ability of CB 2679d achieved after
single intravenous and subcutaneous dosing in the first four
cohorts, followed by daily subcutaneous injections of CB 2679d in
the fifth, and final, cohort. In June 2017, the European Commission
and in September 2017, the U.S. Food and Drug Administration (FDA)
granted orphan drug designations for CB 2679d. Complete trial
results are expected in early 2018.
About CatalystCatalyst 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 http://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, the plans to disclose 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 later trials
will not replicate the results from earlier trials or preclinical
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 described in the “Risk Factors” section of the
Company’s most recent Quarterly Report on Form 10-Q filed with the
SEC on November 2, 2017. Catalyst does not assume any obligation to
update any forward-looking statements, except as required by
law.
Contacts:Investors:Fletcher Payne, CFO Catalyst
Biosciences1.650.871.0761 investors@catbio.com
Media:Josephine Belluardo, Ph.D.LifeSci Public
Relations1.646.751.4361jo@lifescipublicrelations.com
Catalyst Biosciences (NASDAQ:CBIO)
Historical Stock Chart
From Apr 2024 to May 2024
Catalyst Biosciences (NASDAQ:CBIO)
Historical Stock Chart
From May 2023 to May 2024