ContraFect Announces Initiation of Pivotal Phase 3 DISRUPT Study of Exebacase as a treatment for Staph aureus Bacteremia, Inc...
December 20 2019 - 8:00AM
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, announced the initiation of its
Phase 3 DISRUPT (Direct Lysis of Staph aureus Resistant Pathogen
Trial) study of exebacase in patients with Staph aureus bacteremia,
including right-sided endocarditis.
“This is a seminal milestone for our company as
it represents the opportunity to bring a whole new treatment
modality to patients suffering and dying from drug-resistant Staph
aureus infections – a growing public health crisis where meaningful
medical advances have been limited over the last 50 years,” said
Roger J. Pomerantz, MD, President, Chief Executive Officer, and
Chairman of ContraFect. “We look forward to completing what will be
the first pivotal trial designed to demonstrate superiority over
the standard of care for Staph bacteremia over the last 60
years.”
“MRSA bacteremia patients treated with exebacase
in addition to antibiotics in our Phase 2 trial completed earlier
this year had a 43% higher rate of clinical response compared to
those who received antibiotics alone at Day 14, which is a
remarkable improvement over standard of care,” said Cara Cassino,
MD, ContraFect’s Chief Medical Officer and Executive Vice President
of Research and Development. “We are excited by the potential for
exebacase to improve patient outcomes, decrease mortality, reduce
the length of disease-related hospitalizations, and lower the
overall financial burden to the healthcare system, as a result MRSA
bacteremia.”
The Phase 3 DISRUPT study of exebacase is a
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 plans to conduct an interim futility
analysis following the enrollment of approximately 60% of the study
population.
More information about the trial is available at
www.clinicaltrials.gov.
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.
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 the Phase 3 study, statements made by
ContraFect’s chief executive officer and chief medical officer,
Phase 3 study plans and design, whether ContraFect can conduct an
interim analysis following 60% enrollment, 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.. 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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