ContraFect Corporation (Nasdaq:
CFRX), a late 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 announces presentation data showing DLA CF-370 is highly
efficacious in a rabbit pneumonia model of a particularly
hard-to-treat, extensively-drug-resistant (XDR) strain of
Pseudomonas aeruginosa (P. aeruginosa), and also has the ability to
both avoid antimicrobial resistance and suppress antibiotic
resistance to commonly-used antibiotics in vitro. These data were
recently presented at the 32nd European Congress of Clinical
Microbiology & Infectious Diseases (ECCMID) Annual Meeting held
from April 23-26, 2022 in Lisbon, Portugal.
“The wealth of data presented at ECCMID provide
compelling evidence of the prospective potent efficacy and
potentially promising utility of our direct lytic agents against
life-threatening pathogens and combatting antimicrobial
resistance,” stated Cara Cassino, M.D., Executive Vice President of
Research & Development and Chief Medical Officer of ContraFect.
“Importantly, we believe these data highlight the potential of
CF-370 to demonstrate superior clinical outcomes in patients with
hospital-acquired and ventilator-associated pneumonia, infectious
diseases with high morbidity and mortality despite current standard
of care with traditional antibiotics, which face the ongoing threat
of increasing antimicrobial resistance.”
All meeting presentations and posters referenced below are
available on the ContraFect website.
CF-370 ECCMID 2022
Presentations:
The studies discussed below further strengthen
the potential for a new treatment paradigm of CF-370 used in
addition to antibiotics, to achieve optimal efficacy outcomes for
patients. In addition to the efficacy data, multiple serial passage
studies highlight the favorable resistance profile of CF-370,
including the potential ability to suppress resistance to current
standard of care antibiotics. These attributes underpin the
potential ability of direct lytic agents to mitigate antimicrobial
resistance.
Oral Presentation Title: In
vivo efficacy of CF-370 alone and in addition to amikacin in the
rabbit acute pneumonia model caused by an extensively
drug-resistant (XDR) Pseudomonas aeruginosa, AR-769
In this challenging rabbit model of pulmonary
infection, multiple dose regimens of CF-370 administered alone and
in addition to amikacin, significantly reduced bacteria counts by
~3.0 log10 cfu/g tissue (p≤0.0004) compared to amikacin alone and
by ~4.5 log10 cfu/g tissue (p≤0.0003) compared to vehicle controls.
Statistically significant reductions of bacteria counts in
secondary organs of interest, the spleen and the kidney, were seen
when CF-370 was administered in addition to amikacin compared to
the administration of amikacin alone.
Poster Presentations:
Title: Lysin CF-370
exhibits a low propensity for decreased susceptibility in
Gram-negative (GN) ESKAPE pathogens
Utilizing the standard, rigorous 28-day serial
passage method to induce in vitro resistance, CF-370 demonstrated
an extremely low propensity for developing decreased susceptibility
to the Gram-negative ESKAPE pathogens (P. aeruginosa, Acinetobacter
baumannii, Klebsiella pneumoniae and Enterobacter cloacae) and
Escherichia Coli. CF-370’s minimum inhibitory concentration (MIC)
values did not change, except for a 2-fold increase with
Enterobacter cloacae compared to MIC increases ranging from 32-fold
to 512-fold for levofloxacin and ciprofloxacin.
Title: Lysin CF-370
suppresses in vitro resistance in Pseudomonas aeruginosa to
meropenem, tobramycin and levofloxacin
Using the 28-day serial passage method discussed
above, CF-370 further demonstrated the ability to suppress in vitro
resistance in P. aeruginosa to current standard of care antibiotics
- meropenem, tobramycin and levofloxacin. With the addition of only
1/8x MIC of CF-370, resistance of P. aeruginosa was completely
suppressed to both tobramycin and levofloxacin and increased only
2-fold to meropenem, compared to 4-fold, 16-fold and 32-fold MIC
changes without CF-370.
CF-370 and Amurins ECCMID 2022 Poster
Presentation:
Title: Direct lytic
agents, a novel family of antimicrobial agents, have a low
propensity for decreased susceptibility in Gram-negative pathogens
associated with airway infection in Cystic Fibrosis
Using the 28-day serial passage method discussed
above, the Company’s DLAs, including CF-370 and the lead molecules
from its amurin peptide program, all demonstrated an extremely low
propensity for developing decreased susceptibility to Gram-negative
pathogens associated with respiratory infections in Cystic Fibrosis
patients - P. aeruginosa, Stenotrophomonas maltophilia, and
Achromobacter xylosoxidans. All DLAs tested had no change to MIC
values compared to MIC increases ranging from 32-fold to 256-fold
for levofloxacin and ciprofloxacin.
Exebacase ECCMID 2022 Poster Presentations:
Title: In vitro activity of
exebacase against contemporary beta-haemolytic streptococci
recovered from US patients with bloodstream infections
Exebacase demonstrated activity against a total
of 149 BHS recovered from blood cultures collected as part of the
SENTRY antimicrobial surveillance program, representing 5.2% of US
BSI in the program. Exebacase MIC values ranged from 0.5-4.0 mg/L
against Streptococcus agalactiae, Streptococcus pyogenes, and
Streptococcus dysgalactiae, warranting further study of the
potential for exebacase to treat BSI caused by BHS.
The studies below describe the optimization and
expanded use of the exebacase MIC method in order to test
additional target pathogens, such as beta-hemolytic streptococci
(BHS), that have not been studied in clinical trials, but are
relevant to bloodstream infections (BSI), including right-sided
endocarditis. These studies are being performed in late-stage
development to evaluate in vitro activity of exebacase against
contemporary target pathogens relevant to the patient population
under investigation in Phase 3 and for consideration of potential
inclusion in product labeling.
Title: Evaluation of the broth
microdilution MIC method for exebacase against 100 beta-haemolytic
streptococci
Title: Assessment
of exebacase MIC reproducibility: Thirty S. aureus isolates tested
at three sites using three different commercial media lots
About CF-370:
CF-370 is an investigational first-in-class
therapeutic candidate targeting P. aeruginosa, a Gram-negative
pathogen. CF-370 has been engineered to bypass the outer membrane
of the bacteria and to enable potent activity in human serum. The
Company believes this is a significant milestone for direct lytic
agents as native lysins are typically unable to penetrate the outer
membrane of Gram-negative bacteria and consequently unable to work
in vitro in human blood or in animal models. However, based on the
proprietary methods the Company has identified and utilizes to
engineer lysins, CF-370 has exhibited the hallmark in vitro
microbiologic attributes of the lysin class, including rapid and
potent bactericidal activity, synergy with a broad range of
standard of care agents and the eradication of biofilms in
preclinical studies. The promising data from animal models support
the potential therapeutic utility of CF-370 for the treatment of
serious infections caused by P. aeruginosa, including
hospital-acquired and ventilator-associated pneumonias and
pulmonary exacerbations of cystic fibrosis.
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. In the Company’s Phase 2 study of
exebacase, a pre-specified analysis of MRSA-infected patients
showed that the clinical responder rate at Day 14 in patients
treated with exebacase was nearly 43-percentage points higher than
in patients treated with SOC antibiotics alone (74.1% for patients
treated with exebacase compared to 31.3% for patients treated with
SOC antibiotics alone (p=0.010)). In addition to the higher rate of
clinical response, MRSA-infected patients treated with exebacase
showed a 21-percentage point reduction in 30-day all-cause
mortality (p=0.056), a four-day lower median length of hospital
stay and meaningful reductions in hospital readmission rates.
Exebacase was well-tolerated and treatment emergent adverse events,
including serious treatment-emergent serious adverse events (SAEs)
were balanced between the treatment groups. There were no SAEs
determined to be related to exebacase, there were no reports of
hypersensitivity related to exebacase and no patients discontinued
treatment with study drug in either treatment group.
Exebacase is currently being studied in the
Phase 3 DISRUPT superiority design study of exebacase in patients
with Staph aureus bacteremia, including right-sided
endocarditis.
Exebacase has the potential to be a
first-in-class treatment for Staph aureus bacteremia. The
lysin 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 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 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 highly resistant strains of 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 development
as a treatment of MRSA bloodstream infections, including
right-sided endocarditis, when used in addition to SOC
anti-staphylococcal antibiotics.
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: the ECCMID presentations,
data presented and statements made regarding the same, ContraFect’s
ability to discover and develop DLAs as new medical modalities for
the treatment of life-threatening, antibiotic-resistant infections,
CF-370 and exebacase attributes, whether ContraFect will address
life-threatening infections using therapeutic 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 are a novel class of DLAs which
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 the occurrence of any adverse events related to
the discovery, development and commercialization of ContraFect’s
product candidates such as unfavorable clinical trial results,
insufficient supplies of drug products, the lack of regulatory
approval, or the unsuccessful attainment or maintenance of patent
protection and other important risks 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
Media:
Jules AbrahamCORE IRTel: 917-885-7378Email:
Julesa@coreir.com
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