Catalyst Biosciences Announces Interim Phase 1/2 CB 2679d/ISU304 Results at the American Society of Hematology Conference
December 11 2017 - 8:00AM
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 with 75 IU/kg IV BeneFIX, showed that
IV CB 2679d is approximately 22 times more potent and has a
significantly longer half-life (27 vs 21 hours, p = 0.0014) and
mean residence time than BeneFIX (36 hours vs 25 hours, p =
0.00004). Cohorts 2 and 3 compared 75 IU/kg IV CB 2679d with 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 vs
27.6 hours for a IV dose of 75 IU/kg, (p = 0.005). 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 Trial
CB 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 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. For more
information, please visit http://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, 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
Biosciences
1.650.871.0761 investors@catbio.com
Media:Josephine Belluardo, Ph.D.LifeSci Public
Relations1.646.751.4361jo@lifescipublicrelations.com
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