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 that the U.S.
Food and Drug Administration (FDA) has granted Breakthrough Therapy
designation to exebacase for the treatment of MRSA bloodstream
infections (bacteremia), including right-sided endocarditis, when
used in addition to standard-of-care (SOC) anti-staphylococcal
antibiotics in adult patients.
Breakthrough Therapy designation is a program
designed by the FDA to expedite the development and review of
medicines for serious or life-threatening diseases with preliminary
clinical evidence that the investigational therapy may demonstrate
substantial improvement on at least one clinically significant
endpoint over available therapies.
“Since 1958, when vancomycin was first approved,
only one additional agent has gained FDA approval for the treatment
of MRSA bacteremia, based on non-inferiority to vancomycin. Despite
this new agent, clinical failure and mortality rates for this
neglected infectious disease have not improved in over 60 years.”
said Roger J. Pomerantz, MD, President, Chief Executive Officer,
and Chairman of ContraFect. “The decision by the FDA to grant
Breakthrough Therapy designation to exebacase recognizes the urgent
need for new therapies that can impact the lives of patients with
these MRSA infections. Based on the Phase 2 data, we believe
exebacase could be the first anti-infective agent to demonstrate
superior outcomes for these patients.”
The Breakthrough Therapy designation was based
on final data from a Phase 2 superiority trial of exebacase in
patients with Staphylococcus aureus bacteremia, including
endocarditis. This Phase 2 trial evaluated whether the addition of
exebacase to SOC antibiotic therapy improved clinical response
rates compared to treatment with SOC antibitotics alone. In a
pre-specified analysis of the subgroup with MRSA infections, the
clinical responder rate at Day 14 among exebacase-treated patients
was 42.8 percentage points higher than the responder rate among
patients treated with SOC antibiotics alone (74.1% vs 31.3%,
respectively, p=0.010). Treatment with exebacase was also
associated with a 21-percentage point reduction in the 30-day
all-cause mortality (p=0.056), a four day reduction in length of
hospital stay, and meaningful reductions in 30-day hospital
readmission rates in MRSA-infected patients.
“I’m thrilled that the FDA has granted
Breakthrough Therapy designation for exebacase for the treatment of
MRSA bacteremia, a difficult to treat infection with consistently
poor outcomes despite conventional antibiotics. In our
Phase 2 study, the addition of exebacase to standard-of-care
antibiotics to treat MRSA bacteremia was associated with higher
clinical success rates and a reduction in mortality,” said Cara
Cassino, MD, Chief Medical Officer and Executive Vice President of
Research and Development at ContraFect. “We designed the pivotal
Phase 3 DISRUPT study of exebacase for the treatment of Staph
aureus bacteremia, including right-sided endocarditis, to enable
definitive confirmation of these findings. Based on our
interactions with the FDA regarding streamlined development of
exebacase, this single Phase 3 study, in addition to the full
package of data generated to date, may serve as the basis of a
Biologics License Application for FDA review and potential approval
of exebacase. We look forward to continuing to work closely with
the FDA to expedite the development of this promising product
candidate.”
About DISRUPT:
DISRUPT is an ongoing, randomized, double-blind,
placebo-controlled, multi-center Phase 3 clinical study of
exebacase for the treatment of Staph aureus bacteremia, including
right-sided endocarditis, caused by MRSA or methicillin-senstitive
Staph aureus. This study compares the efficacy, safety and
tolerability of exebacase used in addition to SOC antibiotics to
SOC antibiotics alone. The Company expects to enroll approximately
350 patients randomized 2:1 to receive either a single dose of
exebacase administered as a 2-hour IV infusion in addition to SOC
antibiotics or placebo plus SOC antibiotics. The primary efficacy
endpoint will be clinical response at Day 14 in patients with MRSA
bacteremia, including right-sided endocarditis. Secondary endpoints
will include clinical response at Day 14 in All Staph aureus
patients (MRSA and MSSA), 30-day all-cause mortality in MRSA
patients, and clinical response at Day 30 and Day 60 in both MRSA
and All Staph aureus patients. The principal investigator is Dr.
Vance Fowler, Professor of Medicine in the Division of Infectious
Diseases at Duke University.
About Exebacase (CF-301):
Exebacase is a recombinantly-produced lysin
(cell wall hydrolase enzyme) with potent bactericidal activity
against Staph aureus, a major cause of bloodstream infections
(BSIs) also known as bacteremia. Exebacase has the potential to be
a first-in-class treatment for Staph aureus bacteremia. It
has a novel, rapid, and specific mechanism of action that targets
the peptidoglycan cell wall that is vital to Staph aureus bacteria.
In addition, in vitro and in vivo experiments have shown that
exebacase is highly active against biofilms which complicate Staph
aureus infections. Exebacase was licensed from The Rockefeller
University and is being developed at ContraFect.
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, 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 MRSA and P. aeruginosa, which can cause serious infections
such as bacteremia, pneumonia and osteomyelitis.
Follow ContraFect on Twitter @ContraFectCorp and
LinkedIn.
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
ability to discover and develop DLAs as new medical modalities for
the treatment of life-threatening, antibiotic-resistant infections,
statements made regarding MRSA treatment, the Breakthrough Therapy
process and the basis for its grant, comments made by Dr. Pomerantz
and Dr. Cassino, Phase 2 results, Phase 3 study design and plans,
the potential for exebacase to be a first-in-class treatment for
Staph aureus bacteremia, ContraFect’s ability to address life
threatening infections using 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 MRSA
and P. aeruginosa. 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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