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
its plan to initiate a single Phase 3 clinical trial of exebacase
for the treatment of patients with Staphylococcus aureus
bacteremia, including right-sided endocarditis, following its
End-of-Phase 2 meeting with the U.S. Food and Drug Administration
(FDA). ContraFect has obtained concurrence with the FDA on key
design features of the Phase 3 protocol, including the Day 14
primary efficacy endpoint for MRSA bacteremia, including
right-sided endocarditis, and that positive results from this
single Phase 3 study could support a Biologics License Application
(BLA) for approval of exebacase.
“We are very pleased to have obtained clear and
readily actionable FDA guidance to proceed with a single Phase 3
study to support the U.S. registration of exebacase,” said Roger J.
Pomerantz, MD, President, Chief Executive Officer, and Chairman of
ContraFect. “Due to the dramatic increase in antibiotic-resistant
strains of bacteria, our healthcare system urgently requires novel
anti-infective agents, especially those with highly differentiated
mechanisms of action and clinical profiles. Exebacase is the first
product candidate of its class and represents the potential of
direct lytic agents as an entirely new treatment modality.
Exebacase could be the first agent ever to demonstrate superior
efficacy compared to traditional antibiotics in treating patients
with complicated MRSA bacteremia in a Phase 3 study. We appreciate
the efforts of the FDA in working with us to advance exebacase as a
streamlined development program.”
“We are excited to be moving at full speed into
the exebacase Phase 3 study, with the goal of bringing this
potential new medicine to patients who need it as rapidly but as
safely as possible. The 43% higher responder rate at Day 14
demonstrated among exebacase-treated MRSA bacteremia patients,
compared to those who received antibiotics alone, in our Phase 2
study gives us confidence in exebacase’s ability to improve the
clinical cure rates for Staph aureus bacteremia and endocarditis.
This is particularly true for the most difficult-to-treat patients
with complicated MRSA bacteremia, which continues to be a major
health concern the world over,” said Cara Cassino, MD, Chief
Medical Officer and Executive Vice President of Research and
Development at ContraFect.
The Phase 3 DISRUPT trial of exebacase will be a
single, randomized, double-blind, placebo-controlled clinical study
conducted in the U.S. to assess the efficacy and safety of
exebacase in approximately 350 patients with Staph aureus
bacteremia, including right-sided endocarditis. Patients entering
the Phase 3 study will be randomized 2:1 to either exebacase or
placebo, with all patients receiving standard-of-care 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 the All Staph aureus bacteremia patient group (MRSA and
methicillin-sensitive Staph aureus (MSSA)), 30-day all-cause
mortality in MRSA patients, and clinical response at later
timepoints. The company anticipates initiating the Phase 3 study by
the end of 2019, and plans to conduct an interim futility analysis
following the enrollment of approximately 60% of the study
population.
Conference Call
The Company will host a conference call today,
October 2, 2019, at 8:30 a.m. ET to discuss its plans for the
development of exebacase for the treatment of patients with Staph
aureus bacteremia, including endocarditis, following its
End-of-Phase 2 meeting with the FDA. To access the call,
please dial 866-691-5817 (domestic) or 409-216-0839 (international)
and provide Conference ID 5266033. A live webcast of the
presentation will be available on the Investors & Media section
of the Company’s website at www.contrafect.com. The presentation
will also be available as an archived webcast for a limited
time.
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, which is the first lysin to enter clinical studies in
the U.S.
Follow ContraFect on Twitter @ContraFectCorp and
LinkedIn.
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 blood stream infections
(BSIs) also known as bacteremia. It has a novel, rapid, and
specific mechanism of bactericidal action against Staph aureus. By
targeting a conserved region of the cell wall that is vital to
bacteria, resistance is less likely to develop to exebacase. We
have completed a Phase 2 superiority design clinical study with
exebacase which evaluated its safety, tolerability, efficacy and PK
when used in addition to standard-of-care (SOC) antibiotics for the
treatment of Staph aureus bacteremia, including endocarditis, in
adult patients. In a pre-specified analysis of MRSA-infected
patients, the clinical responder rate at day 14 in patients treated
with exebacase was 43% higher than the clinical responder rate in
patients treated with SOC antibiotics alone (74% for patients
treated with exebacase compared to 31% for patients treated with
SOC antibiotics alone (p=0.010)). Additionally, among United States
MRSA patients discharged alive from the hospital, the median length
of stay was reduced by four days and the 30-day all cause
readmission rate was reduced to 16% from 31% in patients treated
with exebacase. We believe exebacase has the potential to be a
first-in-class treatment for Staph aureus bacteremia. Exebacase was
licensed from The Rockefeller University and is being developed at
ContraFect.
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 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, 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, 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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