ContraFect Corporation
(Nasdaq:CFRX), a clinical-stage biotechnology
company focused on the discovery and development of direct lytic
agents (DLAs), including lysins and amurin peptides, as new medical
modalities for the treatment of life-threatening,
antibiotic-resistant infections, today announced that it has
selected its next product candidate, CF-370, an engineered lysin
targeting Pseudomonas aeruginosa (P. aeruginosa). CF-370 was
nominated for further development based on its potent in vitro
bactericidal and antibiofilm activity and in vivo activity and
tolerability in preclinical animal models, favorable manufacturing
profile, and potentially favorable intellectual property rights for
a proprietary engineered lysin. The Company will rapidly
advance CF-370 into IND-enabling studies, as the first lysin with
potential to address systemic human infections caused by the
Gram-negative pathogen P. aeruginosa. The Company expects to
present the detailed preclinical data supporting the advancement of
CF-370 at an upcoming scientific conference.
“We are excited to announce the nomination of
CF-370 as our next product candidate. The compelling preclinical
findings showed potent activity against resistant P. aeruginosa
both in vitro and in vivo, as well as excellent tolerability in
animals,” said Cara Cassino, MD, ContraFect’s Chief Medical Officer
and Executive Vice President of Research & Development. “We
believe CF-370 offers a potential new therapeutic modality to
address the unmet need for treatment of serious systemic infections
caused by multi-drug resistant P. aeruginosa, which is listed as a
serious threat in the CDC’s 2019 Antibiotic Resistance Threats
Report.”
In preclinical rabbit pneumonia models, single
doses of CF-370 alone and in combination with the antibiotic,
meropenem, were tested against multi-drug resistant P. aeruginosa
to evaluate survival and bacterial burden in lung and secondary
organs. In these models, strong efficacy was observed for CF-370 as
a monotherapy, showing rabbits dosed with CF-370 alone had longer
survival, as compared to vehicle control, and reductions in
bacterial burden in lung, kidney and spleen with single doses of
CF-370. Synergy with meropenem was also noted with greater
reductions in bacterial burden compared to monotherapy. In these
models, CF-370 was well tolerated with no adverse clinical
consequences and no deaths among animals infected with P.
aeruginosa.
About ContraFect:
ContraFect is a biotechnology company focused on
discovering and developing differentiated biologic therapies 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 platform of DLAs, which
include lysins and amurin peptides. Lysins are a new class of DLAs
which are recombinantly produced antimicrobial proteins with a
novel mechanism of action associated with the rapid killing of
target bacteria, eradication of biofilms and synergy with
conventional antibiotics. Amurin peptides are a new class of DLAs,
which exhibit broad-spectrum activity against a wide range of
antibiotic-resistant Gram-negative pathogens, including Pseudomonas
aeruginosa (P. aeruginosa), Acinetobacter baumannii, and
Enterobacter species. We believe that the properties of our lysins
and amurin peptides will make them suitable for targeting
antibiotic-resistant organisms, such as methicillin-resistant Staph
aureus (MRSA) and P. aeruginosa, which can cause serious infections
such as bacteremia, pneumonia and osteomyelitis. We have completed
a Phase 2 clinical trial for the treatment of Staph aureus
bacteremia, including endocarditis, with our lead lysin candidate,
exebacase (CF-301), which is the first lysin to enter clinical
studies in the U.S.
Follow ContraFect on Twitter @ContraFectCorp and
LinkedIn.
About Pseudomonas aeruginosa (P.
aeruginosa):
P. aeruginosa is a gram-negative pathogen which
readily develops resistance to conventional antibiotics resulting
in the emergence of multidrug resistant (“MDR”) strains, which have
become common in many hospitals and regions. P. aeruginosa is a
major cause of hospital-acquired infections and is a particularly
important cause of infections in immunocompromised hosts and is
also a major pathogen in burn and surgical wound infections. P.
aeruginosa is the most common pathogen isolated from adults with
cystic fibrosis, and is the most common cause of respiratory
failure in cystic fibrosis and responsible for the deaths of the
majority of these patients.
Invasive P. aeruginosa infections, including
ventilator associated pneumonia, blood stream infections,
complicated urinary tract infections, and infections following
surgery carry some of the highest rates of mortality among hospital
acquired infections. Infections caused by multidrug resistant
P. aeruginosa are associated with high all-cause mortality,
hospital mortality and higher health-care related costs, as
compared to infections caused by susceptible strains.
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 ContraFect’s
End-of-Phase 2 Meeting with the FDA, Phase 3 plans, designs,
results and timing, statements made regarding ContraFect’s ability
to discover and develop DLAs as new medical modalities for the
treatment of life-threatening, antibiotic-resistant infections,
statements made regarding CF-370, including ContraFect’s ability to
advance CF-370 into IND enabling studies and the presentation of
pre-clinical data, statements made by ContraFect’s chief executive
officer and chief medical officer, ContraFect’s ability to discover
and develop DLAs as new medical modalities for the treatment of
life-threatening, antibiotic-resistant infections, the planned call
and webcast, in vitro and in vivo study results, ContraFect’s
ability to address life threatening infections using its
therapeutic product candidates from its DLA platform, whether
lysins are a new class of DLAs which are recombinantly produced,
antimicrobial proteins with a novel mechanism of action associated
with the rapid killing of target bacteria, eradication of biofilms
and synergy with conventional antibiotics, whether amurins exhibit
broad-spectrum activity against a wide range of
antibiotic-resistant Gram-negative pathogens, and whether the
properties of ContraFect’s lysins and amurins will make them
suitable for targeting antibiotic-resistant organisms, such as
Staph aureus and P. aeruginosa., the potential for exebacase to be
a first-in-class treatment for Staph aureus bacteremia, statements
made regarding exebacase and Phase 2 study results. 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
under the caption “Risk Factors” 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
Lauren StivalStern Investor RelationsTel: 212-362-1200Email:
lauren.stival@sternir.com
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