Catalyst Biosciences Announces Achievement of Stable Normal Factor IX Blood Levels in a Preclinical Subcutaneous Dosing Model...
26 June 2017 - 10:01PM
-- Data support ongoing clinical trial in
individuals with hemophilia B --
Catalyst Biosciences, Inc. (Nasdaq:CBIO), a clinical-stage
biopharmaceutical company focused on developing novel medicines to
address hematology indications, today announced positive
preclinical results of CB 2679d/ISU304, its next-generation
coagulation Factor IX, in a well-validated preclinical model of
hemophilia B. The results demonstrate the attractive
pharmacokinetic and pharmacodynamic profile of CB 2679d based on
bioavailability, potency, time to maximal concentration, and
half-life.
The Company’s Factor IX preclinical program, including the
results being presented at the International Society on Thrombosis
and Haemostasis (ISTH) Meeting in July 2017, supported the
initiation of an ongoing Phase 1/2 proof-of-concept clinical trial
evaluating CB 2679d for subcutaneous prophylaxis.
At the meeting, the Company will also have a Factor VIIa Poster
Presentation which supports the initiation of a Phase 2/3 clinical
trial to evaluate subcutaneous dosing of marzeptacog alfa
(activated); the Phase 2 portion of the trial is expected to
commence by the end of 2017.
“Catalyst’s CB 2679d corrected severe hemophilia to normal
coagulation activity in hemophilia B dogs after only six daily
subcutaneous doses,” said Howard Levy, M.B.B.Ch., Ph.D., M.M.M.,
Catalyst’s Chief Medical Officer. “Given the potency and
pharmacokinetic profile of CB 2679d observed in our preclinical
studies, we are looking forward to open-label results from the
ongoing Phase 1/2 subcutaneous dosing study in individuals with
hemophilia B, as well as daily dosing results, towards the end of
this year.”
Oral Factor IX PresentationPharmacokinetics and
Pharmacodynamics of Daily Subcutaneously Administered CB
2679d/ISU304 In Hemophilia B Dogs (abstract #OC 10.3) Howard
Levy, Timothy Nichols, Elizabeth Merricks, Robin
Raymer, and Andrew Hetherington (Oral Communications Session:
Future Biotherapeutics for Hemophilia A and B. Monday, July 10,
2017 at 10:00 am CEST)The authors tested daily subcutaneous (SQ)
doses of CB 2679d/ISU304 in hemophilia B dogs for six days. Factor
IX antigen and activity were measured at various time points. The
results are summarized as follows:
- CB 2679d/ISU304 corrected severe hemophilia to normal in
hemophilia B dogs, after six daily subcutaneous doses
- Daily SQ dosing of CB 2679d after six doses had peak Factor IX
activity levels of 60 and 53 percent at 126 hours
- Trough activity levels 24 hours after six daily doses were 56
and 40 percent respectively
- The progressive increase in Factor IX activity levels after
daily SQ dosing of CB 2679d supported the initiation of the ongoing
Phase 1/2 proof-of-concept subcutaneous dosing study in individuals
with hemophilia B with the target of achieving normal Factor IX
activity trough levels
- There were no emergent clinical adverse events or lab
abnormalities recorded
Factor VIIa Poster PresentationPharmacokinetics
and Pharmacodynamics of Subcutaneously Administered Marzeptacog
Alfa (Activated) in Hemophilia B Mice (abstract #PB 1119) Howard
Levy, Nassim Usman, and Andrew Hetherington (Tuesday,
July 11, 2017 from 12:00-13:15pm CEST)The authors tested
subcutaneous doses of marzeptacog alfa (activated) in hemophilia B
mice. Factor VIIa antigen and activity were measured at various
time points. The results are summarized as follows:
- Daily subcutaneous dosing (0.5 mg/kg) had trough levels of
marzeptacog alfa (activated) 29.9 to 76.9 (mean 43.4) ng/mL and
increased two hours after administration to 267.4 to 362 (mean
323.9) ng/mL
- Daily subcutaneous dosing (1 mg/kg) achieved trough levels of
marzeptacog alfa (activated) 50 to 80.9 (mean 63.7) ng/mL and
increased two hours after administration to 230.8 to729.5 (mean
471.9) ng/mL
- Increased potency of marzeptacog alfa (activated), blood drug
levels and reduction in activated partial thromboplastin time
(aPTT) achieved, support the initiation of a Phase 2/3 subcutaneous
dosing study in individuals with hemophilia A and B with
inhibitors, with a target of achieving normal coagulation
pharmacodynamics
The abstracts can be found on the ISTH website. A PDF of the
Factor IX oral presentation slides and the Factor VIIa poster will
be available on the Company’s website on Monday, July 10 and
Tuesday, July 11, respectively.
About Factor IX CB 2679d/ISU304 is a
next-generation coagulation Factor IX variant that is being
evaluated in a Phase 1/2 proof-of-concept clinical trial
in South Korea. Catalyst believes that CB 2679d/ISU304 may
allow for subcutaneous prophylactic treatment of individuals with
hemophilia B. Learn more about Factor IX.
About Factor VIIaMarzeptacog alfa (activated)
is a high potency next-generation Factor VIIa that is initially
being developed for the subcutaneous prophylactic treatment of
individuals with severe hemophilia A and B with inhibitors. An
inhibitor is a potential complication for individuals with
hemophilia receiving factor replacement therapy resulting from the
production of antibodies against the replacement factor. Learn more
about Factor VIIa.
About Hemophilia and Factor Replacement Therapy
Hemophilia, 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.
Individuals with hemophilia suffer from spontaneous bleeding
episodes as well as substantially prolonged bleeding times upon
injury.
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, 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, the potential uses and benefits of CB 2679d/ISU304 and
marzeptacog alpha (activated) and development plans for these
product candidates are forward-looking statements. Examples of such
statements include, but are not limited to, statements relating to
preclinical models showing efficacy or therapeutically relevant
blood levels of these product candidates following subcutaneous
dosing, Catalyst’s clinical trial timelines, including the
initiation of efficacy Phase 2/3 study for marzeptacog alfa
(activated) in 2017, the anticipated completion of a Phase 1/2
proof-of-concept study for CB 2679d/ISU304 or the plans to have
results from this study by the end of 2017, and the potential uses
and benefits of subcutaneously dosed marzeptacog alfa (activated)
or CB 2679d/ISU304. 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 the human trials will not
replicate the results from animal studies, that trials and
enrollment may be delayed and may not have satisfactory outcomes,
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 Annual Report on Form 10-K filed with the SEC
on March 8, 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, Inc.
650.871.0761
investors@catbio.com
Media:
Denise Powell
Red House Consulting, LLC
510.703.9491
denise@redhousecomms.com
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