ContraFect Announces First Patient Dosed in Pivotal Phase 3 DISRUPT Study of Exebacase as a Treatment for Staph aureus Bacter...
January 10 2020 - 7:00AM
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, today announced the first patient
has been dosed in the Phase 3 DISRUPT (Direct Lysis of Staph aureus
Resistant Pathogen Trial) study of exebacase in patients with Staph
aureus bacteremia, including right-sided endocarditis.
“We are pleased by the rapid enrollment and
dosing of the first patient in the Phase 3 pivotal study of our
lead lysin candidate, exebacase, which we believe has the potential
to improve clinical outcomes for patients suffering and dying from
Staph aureus bacteremia, particularly those infected with difficult
to treat methicillin-resistant Staph aureus (MRSA). We are
confident in the protocol for the Phase 3 study which aims to be
the first pivotal study to demonstrate superiority over standard of
care antibiotics alone for the treatment of MRSA bacteremia,” said
Cara Cassino, MD, Chief Medical Officer and Executive Vice
President of Research and Development of ContraFect. “We believe
exebacase and our pipeline of DLA candidates have the potential to
be game changers in the fight against drug-resistant
pathogens.”
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 complicated 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 patients (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 medical officer, including whether exebacase has
the potential to improve clinical outcomes for patients suffering
and dying from Staph aureus bacteremia, 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 methicillin-resistant 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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