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,
announces today presentation data showing that the Company’s lead
product candidate, exebacase, which has been designated as a
Breakthrough Therapy for development as a treatment for
methicillin-resistant Staphylococcus aureus (MRSA) bloodstream
infections by the FDA, was effective in a rabbit model of
implant-associated osteomyelitis. Additional data was also
presented which further supports that exebacase has a low
propensity for the development of antimicrobial resistance, and
also has the ability to suppress antibiotic resistance to standard
of care antibiotics in vitro. These data were recently presented at
the ASM Microbe Conference held in Washington, D.C. from June 9-13,
2022.
“While we are keenly focused on continued
enrollment in our Phase 3 trial of exebacase and the upcoming
interim futility analysis from the study, we continue to amass
evidence of the potential utility of exebacase against antibiotic
resistant staphylococcus infections in a variety of clinical
contexts,” commented Roger Pomerantz, M.D., ContraFect’s Chairman,
CEO and President. “And together with our presentations at ECCMID
earlier this year, these data further underpin the foundation of
our direct lysin agent platform, and the potential for these agents
to provide patients with meaningful improvements in clinical
outcomes of antibiotic resistant infections.”
Poster
Presentations:Title: Locally Delivered
Antistaphylococcal Lysins Exebacase or CF-296 is Active in
Methicillin-Resistant Staphylococcus Aureus Implant-Associated
Osteomyelitis
In this rabbit study, either exebacase or CF-296
was delivered locally into the medial tibia (both with and without
systemic daptomycin) to treat osteomyelitis resulting from
methicillin-resistant Staphylococcus aureus (MRSA) implantation,
all compared to a placebo control (six groups total). While all
treatment groups showed activity, the greatest reductions in the
concentration of bacteria colonies (CFU) compared to daptomycin
also were demonstrated with exebacase alone (3.87 log10 CFU
reduction (p=0.007)), or used in addition to daptomycin (3.48 log10
CFU reduction (p=0.0015)). A notable reduction in CFUs was also
seen with CF-296 used in addition to daptomycin (3.17 log10 CFU
reduction (p=0.0064)), compared to daptomycin alone. These results
demonstrate that lysins offer a potentially effective strategy for
treating implant-associated MRSA osteomyelitis infections.
Title: Lysin Exebacase Has a
Low Propensity for Resistance Development and Suppresses the
Emergence of Resistance to Anti-Staphylococcal Antibiotics
These in vitro studies demonstrate the low
propensity for the development of resistance to exebacase in both
MRSA and methicillin-sensitive S. aureus (MSSA) strains. 28-day
serial passage resistance assays demonstrated that the minimum
inhibitory concentration (MIC) of exebacase was not increased
against MRSA and MSSA. In comparison, 28-day serial passage studies
of daptomycin and vancomycin (against MRSA), and oxacillin (against
MSSA), demonstrated the emergence of resistance to each of these
standard of care antibiotics as evidenced by the need for greatly
increased concentrations in order to suppress the bacteria. Of
note, the addition of sub-MIC concentrations of exebacase (e.g.
1/16x MIC) to the respective antibiotics suppressed the emergence
of resistance of S. aureus to daptomycin, vancomycin or
oxacillin.
These posters are available on the ContraFect website.
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.
Activities related to exebacase during the
period of performance under the contract will be funded in part
with federal funds from HHS; ASPR; BARDA, under contract number
75A501212C00021.
Forward-Looking Statements
This press release contains, and our officers
and representatives may make from time to time, “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 poster presentations and data presented, statements
made by Dr. Pomerantz, ContraFect’s ability to discover and develop
DLAs as new medical modalities for the treatment of
life-threatening, antibiotic-resistant infections, exebacase
attributes, including its effectiveness, propensity for resistance
and antibiotic resistance suppression, whether ContraFect will
address life-threatening infections using therapeutic candidates
from its DLA platform, whether exebacase has the potential to be a
first-in-class treatment for Staph aureus bacteremia, 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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