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 publication of the exebacase Phase 2 study results in the July
1, 2020 issue of the Journal of Clinical Investigation. The study
results established clinical proof-of-concept for exebacase and
informed the design of the ongoing Phase 3 DISRUPT (Direct Lysis of
Staph aureus Resistant Pathogen Trial) study of exebacase for the
treatment of patients with life-threatening Staph aureus
bloodstream infections (BSIs), including right-sided endocarditis.
“This is an important study. Complicated Staph
aureus bloodstream infections are common, potentially lethal and
currently available antibiotic treatments are suboptimal.
Innovative new therapeutic approaches are desperately needed. The
exebacase Phase 2 study demonstrated meaningful improvements in
clinical outcomes among patients who received exebacase and I look
forward to the results of the ongoing Phase 3 superiority study,”
said Vance Fowler, M.D., Study Principal Investigator and Professor
of Medicine of Duke University School of Medicine.
“The publication of the exebacase Phase 2 study
results in the prestigious Journal of Clinical Investigation
provides recognition of the novelty and importance of this
potential new therapeutic approach for life-threatening infections.
This first ever demonstration of the potential clinical utility of
lysins supported the FDA Breakthrough Therapy designation, and we
look forward to working closely with the FDA under this designation
as we progress the program towards BLA submission,” said Cara
Cassino, M.D., Chief Medical Officer and Executive Vice President
of Research and Development at ContraFect.
Summary of the Exebacase Phase 2 Trial
In the Phase 2 superiority-design study, 121
subjects with Staph aureus BSI, including endocarditis, were
randomized 3:2 to receive either a single dose of exebacase or
placebo. All patients received standard-of-care (SOC) antibiotics.
The study evaluated whether the addition of exebacase to SOC
antibiotic therapy improved clinical response rates compared to
treatment with SOC antibiotics alone. The primary efficacy endpoint
was clinical outcome (responder rate) at day 14.
Clinical responder rates at day 14 were 70.4%
and 60.0% in the exebacase + antibiotics and antibiotics alone
groups, respectively (p-value=0.314), and were 42.8 percentage
points higher in the pre-specified MRSA subgroup (p-value=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 median length of hospital stay, and
meaningful reductions in 30-day hospital readmission rates in
MRSA-infected patients.
Exebacase was generally safe and well tolerated,
with adverse events consistent with those expected in critically
ill, hospitalized patients with potentially life-threatening S.
aureus BSI, including endocarditis and/or underlying comorbid
conditions. Rates of adverse events (AEs) were similar in both
groups. There were no serious AEs determined to be related to
exebacase, no reports of hypersensitivity related to exebacase and
no patients discontinued treatment with study drug in either
treatment group.
About DISRUPT:
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
enrolled in the Phase 3 study will be randomized 2:1 to receive
either exebacase or placebo, with all patients receiving 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 the All Staph aureus patients (MRSA and
methicillin-sensitive Staph aureus (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. Health resource
utilization, including length of hospital stay, length of time in
ICU and 30-day hospital readmission rates, will also be evaluated.
The company plans to conduct an interim futility analysis following
the enrollment of approximately 60% of the study population. 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
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.
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 novel 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 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.
Exebacase, currently being studied in a pivotal Phase 3 clinical
study, was granted Breakthrough Therapy designation by the FDA for
the treatment of MRSA bloodstream infections (bacteremia),
including right-sided endocarditis, when used in addition to
standard-of-care anti-staphylococcal antibiotics in adult
patients.
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 by Dr. Pomerantz and Dr. Cassino, statements
regarding the Phase 2 trial results and exebacase, whether the
Phase 2 results demonstrated clinical benefit and supported
Breakthrough Therapy designation, whether exebacase has the
potential 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
Carlo TanziKendall Investor RelationsTel: 617-914-0008Email:
ctanzi@kendallir.com
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