ContraFect Corporation
(Nasdaq:CFRX), a clinical-stage biotechnology
company focused on the discovery and development of protein and
antibody therapeutics for life-threatening, drug-resistant
infectious diseases, today announced that it has completed
enrollment in the Phase 2 clinical trial evaluating its
first-in-class lysin, CF-301, as a potential treatment for
Staphylococcus aureus (Staph aureus) bacteremia including
endocarditis.
"We are very pleased to have completed
enrollment of this Phase 2 superiority study, which is a major
milestone in the development of exebacase (CF-301) as a potential
new treatment option for patients with Staph aureus bacteremia
including endocarditis. We thank the investigators, study sites and
patients for their ongoing participation,” said Cara Cassino, M.D.,
Chief Medical Officer and Executive Vice President of Research and
Development at ContraFect. "Staph aureus bacteremia and
endocarditis continue to be associated with substantial morbidity
and mortality despite conventional antibiotics. We look forward to
the topline results of the Phase 2 study later this year, which
will inform us of the potential for CF-301 to improve clinical
outcomes for these serious, potentially life threatening Staph
aureus infections.”
The multi-center, multi-national, randomized,
double-blind, placebo-controlled Phase 2 superiority study is
intended to evaluate the potential for CF-301, used in addition to
standard-of-care (SOC) antibiotics, to improve clinical cure rates
compared to SOC antibiotics alone. The study is ongoing at
investigational sites in the United States, Europe, Latin America,
Russia and Israel. Approximately 115 patients were planned to be
randomized 3:2 to receive either a single dose of CF-301 or placebo
administered via intravenous infusion in addition to SOC
anti-staphylococcal antibiotics. The primary objectives of the
study are to evaluate the safety, tolerability, pharmacokinetics,
and efficacy of CF-301.
More information about the study is available at
www.clinicaltrials.gov.
About Staphylococcus aureus
bacteremia:
In the U.S. alone, there are approximately 200,000
hospitalizations for Staph aureus bacteremia annually. Mortality
rates from this bloodstream infection have been reported as ranging
from 20-40% despite conventional antibiotics. Staph aureus
bacteremia may lead to infectious endocarditis, a serious infection
affecting the heart valves. The incidence of infective endocarditis
in the U.S. has increased over the past decade and is likely due to
the growth of the at-risk populations, such as older, diabetic and
hemodialysis patients. Staph aureus endocarditis remains difficult
to treat with current standard of care antibiotics. One reason for
this is biofilm formation which prevents antibiotics from
eradicating the bacteria, leading to the need for long courses of
antibiotic therapy, which are often unsuccessful and necessitate
surgery to eradicate bacteria from infected heart valves. Emerging
resistance to conventional antibiotics such as vancomycin and
daptomycin represents an additional serious threat which may have
serious consequences in terms of increasing morbidity, mortality
and health care utilization.
About exebacase (CF-301):
Exebacase (CF-301) is a recombinant
bacteriophage-derived lysin with potent bactericidal activity
against Staph aureus, a major cause of blood stream infections, or
bacteremia. CF-301 has the potential to be a first-in-class
treatment for Staph aureus bacteremia. It has a novel, rapid,
and specific mechanism of bactericidal action against Staph aureus
and does not impact the body's natural bacterial flora. By
targeting a conserved region of the cell wall that is vital to
bacteria, resistance is less likely to develop to CF-301.
Combinations of CF-301 with standard of care antibiotics
significantly increased bacterial killing and survival in animal
models of disease when compared to treatment with antibiotics or
CF-301 alone. In addition, in vitro and in vivo experiments have
shown that CF-301 is highly active against biofilm infections.
CF-301 was licensed from The Rockefeller University and is being
developed at ContraFect. It is the first lysin to enter clinical
studies in the U.S.
About ContraFect:
ContraFect is a biotechnology company focused on
discovering and developing therapeutic protein and antibody
products for life-threatening, drug-resistant infectious diseases,
particularly those treated in hospital settings. An estimated
700,000 deaths worldwide each year are attributed to
antimicrobial-resistant infections. We intend to address life
threatening infections using our therapeutic product candidates
from our lysin and monoclonal antibody platforms to target
conserved regions of either bacteria or viruses (regions that are
not prone to mutation). ContraFect's initial product candidates
include new agents to treat antibiotic-resistant infections such as
MRSA (Methicillin-Resistant Staphylococcus aureus) and influenza.
ContraFect’s lead product candidate, exebacase (CF-301), is
currently in a Phase 2 clinical trial for the treatment of
Staphylococcus aureus (Staph aureus) bacteremia, including
endocarditis and is the first lysin to enter clinical studies in
the U.S. ContraFect is also conducting research focused on
the discovery of lysins to target Gram-negative bacteria.
Forward-Looking Statements:
This press release contains, and our officers
and representatives may make from time to time, “forward-looking
statements” within the meaning of the U.S. federal securities
laws. Forward-looking statements can be identified by words
such as “projects,” “may,” “will,” “could,” “would,” “should,”
“believes,” “expects,” “anticipates,” “estimates,” “intends,”
“plans,” “potential,” “promise” or similar references to future
periods. Examples of forward-looking statements in this release
include, without limitation, statements regarding our ability to
discover and develop protein and antibody therapeutics for
life-threatening, drug-resistant infectious diseases, the potential
for CF-301 to be a treatment for Staph aureus bacteremia including
endocarditis, whether completion of enrollment constitutes a major
milestone in the development of exebacase, the timing of the
announcement of topline results and whether they will inform us of
the potential for CF-301 to improve clinical outcomes for Staph
aureus infections, whether the Phase 2 trial will evaluate the
potential for CF-301 used in addition to SOC antibiotics to improve
clinical cure rates compared to SOC antibiotics alone, our ability
to address life threatening infections using our therapeutic
product candidates from our lysin and monoclonal antibody platforms
to target conserved regions of either bacteria or viruses, whether
our initial product candidates can treat antibiotic-resistant
infections such as MRSA and influenza, our ability to discover new
lysins targeting Gram-negative bacteria, statements regarding
primary study objectives, enrollment, randomization, Staph aureus
bacteremia and in vitro and in vivo experiments. Forward-looking
statements are statements that are not historical facts, nor
assurances of future performance. Instead, they are based on
ContraFect’s current beliefs, expectations and assumptions
regarding the future of its business, future plans, strategies,
projections, anticipated events and trends, the economy and other
future conditions. Because forward-looking statements relate to the
future, they are subject to inherent risks, uncertainties and
changes in circumstances that are difficult to predict and many of
which are beyond ContraFect’s control, including those detailed in
ContraFect's filings with the Securities and Exchange
Commission. Actual results may differ from those set forth in
the forward-looking statements. Important factors that could cause
actual results to differ include, among others, our ability to
develop treatments for drug-resistant infectious diseases. Any
forward-looking statement made by ContraFect in this press release
is based only on information currently available and speaks only as
of the date on which it is made. Except as required by applicable
law, ContraFect expressly disclaims any obligations to publicly
update any forward-looking statements, whether written or oral,
that may be made from time to time, whether as a result of new
information, future developments or otherwise.
Investor Relations Contacts:
Michael MessingerContraFect CorporationTel: 914-207-2300Email:
mmessinger@contrafect.com
Matthew ShinsekiStern Investor RelationsTel: 212-362-1200Email:
matthew@sternir.com
ContraFect (NASDAQ:CFRX)
Historical Stock Chart
From Mar 2024 to Apr 2024
ContraFect (NASDAQ:CFRX)
Historical Stock Chart
From Apr 2023 to Apr 2024