New data include secondary endpoint
analyses of clinical responder rates at Day 7, End of Treatment,
and Test of Cure, and pre-specified analyses of the clinical
responder rates by final diagnosis at Day 14
ContraFect Corporation
(Nasdaq:CFRX), a clinical-stage biotechnology
company focused on the discovery and development of biologic
therapies for life-threatening, drug-resistant infectious diseases,
today announced that new data from its Phase 2 clinical trial of
exebacase for the treatment of Staphylococcus aureus (Staph aureus)
bacteremia including endocarditis was presented by Vance G. Fowler,
M.D., Professor of Medicine in the Division of Infectious Diseases,
Duke University at a late-breaker session at the 29th European
Congress of Clinical Microbiology and Infectious Diseases (ECCMID).
The oral presentation, titled “Exebacase (Lysin CF-301) Improved
Clinical Responder Rates In Methicillin Resistant Staphylococcus
Aureus (MRSA) Bacteremia Including Endocarditis Compared To
Standard Of Care Antibiotics Alone In A First-in-Patient Phase 2
study,” reported new data demonstrating clinically meaningful
increases in clinical responder rates in the pre-specified MRSA
subgroup treated with exebacase, including a 22.9% higher responder
rate at Day 7 and a 16.9% higher responder rate at Test of Cure,
compared to MRSA patients treated with standard of care antibiotics
(SOC) alone. Pre-specified analyses of data from the overall
population also showed that patients with complicated bacteremia
had a 20.3% higher clinical responder rate with exebacase compared
to those who received SOC alone (78.6% and 58.3% for the exebacase
+ SOC and SOC alone groups, respectively).
“We are excited by the impressive results
observed in the pre-specified MRSA subgroup treated with exebacase.
MRSA bloodstream infections remain an area of extremely high unmet
medical need with few treatment options, and our Phase 2
superiority design study demonstrated a clinical responder rate of
74.1% at Day 14 in the MRSA subpopulation, which represents a 42.8%
improvement over standard of care antibiotics alone,” said Dr.
Roger J. Pomerantz, President and Chief Executive Officer, and
Chairman of ContraFect. “We are also pleased to see the 20.3%
higher clinical responder rate at Day 14 among all complicated
bacteremia patients treated with exebacase compared to those
treated with SOC alone, further validating our belief that
exebacase may play a critical role in the treatment of complicated
bacteremia, as well as resistant infections such as MRSA.”
Clinical Responder Rates of
Pre-specified MRSA Subgroup:
|
Day 7 |
Day 14 |
End of Treatment |
Test of Cure |
Number of Patients |
Exebacase
+ SOC |
SOCalone |
Exebacase+
SOC |
SOCalone |
Exebacase+
SOC |
SOCalone |
Exebacase+
SOC |
SOCalone |
Responders/Total(Response %)
|
18/27(66.7%) |
7/16(43.8%) |
20/27(74.1%) |
5/16(31.3%) |
14/27(51.9%) |
7/16(43.8%) |
13/27(48.2%) |
5/16(31.3%) |
Cara Cassino, M.D., Chief Medical Officer and
Executive Vice President of Research and Development at ContraFect,
said, “We are very encouraged by these results which strongly
suggest the potential for exebacase to offer substantial clinical
benefit to patients with MRSA bloodstream infections, and we look
forward to advancing exebacase into a definitive Phase 3
trial.”
The Phase 2 clinical trial of exebacase is an
international, multi-center, randomized, double-blind,
placebo-controlled clinical trial in patients with Staph aureus
bacteremia including endocarditis. This superiority design study
compared the responder rates with exebacase administered on a
background of antibiotic therapy to antibiotics alone. The primary
efficacy endpoint in this study was the clinical responder rate at
Day 14 in patients with Staph aureus who received study drug.
Clinical responder rates at Day 7, End of Treatment (EOT) and Test
of Cure (TOC) were evaluated in the same population as secondary
efficacy endpoints. The clinical responder rates at Day 7, Day 14,
EOT and TOC were 71.8%, 70.4%, 62.0% and 54.9%, respectively, for
patients treated with exebacase compared to 68.9%, 60.0%, 62.2% and
55.6%, respectively for patients treated SOC alone.
The detailed presentation can be accessed on the News/Events
page of the ContraFect website.
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 lysin platform and
through the use of other novel agents. Lysins are a new therapeutic
class of bacteriophage-derived, 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. We believe that the
properties of our lysins will make them suitable for targeting
antibiotic-resistant organisms, such as Staph aureus and
Pseudomonas aeruginosa (P. aeruginosa), which can cause serious
infections such as bacteremia, pneumonia and osteomyelitis. Our
lead lysin candidate, exebacase is completing a Phase 2 clinical
trial for the treatment of Staph aureus bacteremia, including
endocarditis and is the first lysin to enter clinical studies in
the U.S.
Follow ContraFect on Twitter @ContraFectCorp and
LinkedIn.
About Exebacase (CF-301):
Exebacase (CF-301) 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. Exebacase has the
potential to be a first-in-class treatment for Staph aureus
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. 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.
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 whether the
additional data from the Phase 2 trial to be presented at ECCMID is
positive, whether the data, which includes secondary endpoint
analyses of clinical responder rates at Day 7, End of Treatment,
and Test of Cure, and pre-specified analyses of the clinical
responder rates by final diagnosis at Day 14 are considered new,
whether the MRSA data that showed increased response previously
reported at Day 14 persists at all timepoints, whether MRSA
patients treated with exebacase demonstrated an early and durable
increase in clinical responder rates through Test of Cure compared
to patients treated with SOC alone, the Company’s ability to
discover and develop biological therapies for life-threatening,
drug-resistant infectious diseases, whether presented data from the
Phase 2 study of exebacase is new, whether the data demonstrated
clinically meaningful increases in clinical responder rates in the
pre-specified MRSA subgroup treated with exebacase compared to MRSA
patients treated with SOC alone, whether the pre-specified analyses
of data from the overall population showed that patients with
complicated bacteremia had a higher clinical responder rate with
exebacase compared to those who received SOC alone, whether
exebacase may play a critical role in the treatment of complicated
bacteremia and resistant infections such as MRSA, whether the
results strongly suggest the potential for exebacase to offer
substantial clinical benefit to patients with MRSA bloodstream
infections, whether the Company will advance exebacase into a
definitive Phase 3 trial, statements made which include responder
rates, the Company’s ability to address life threatening infections
using its therapeutic product candidates from its lysin platform
and through the use of other novel agents, whether lysins are a new
therapeutic class of bacteriophage-derived, 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 the properties
of the Company’s lysins will make them suitable for targeting
antibiotic-resistant organisms, such as Staph aureus and P.
aeruginosa, whether exebacase has the potential to be a
first-in-class treatment for Staph aureus bacteremia, whether
resistance is less likely to develop to exebacase, whether
exebacase is highly active against biofilms which complicate Staph
aureus infections and the accuracy of all responder rate
percentages. 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 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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