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,
announces today that ANSM, the French National Agency for the
Safety of Medicines and Health Products, has authorized its
Clinical Trial Application (CTA) for the study of intra-articularly
administered exebacase, in the setting of a minimally-invasive
arthroscopic debridement, antibiotics, irrigation, and retention
(DAIR) procedure in patients with chronic prosthetic joint
infection (PJI) of the knee due to Staphylococcus aureus (S.
aureus) or Coagulase-Negative Staphylococci (CoNS).
“This is a significant milestone for our company
as it represents the next opportunity for exebacase to recapitulate
the positive and durable results we have observed clinically in the
compassionate use setting, after dosing 16 patients. Exebacase
presents the potential for a truly revolutionary change to the
current treatment paradigm for patients with prosthetic joint
infections, which consists of the chronic use of ineffective
antibiotic agents leading to expensive and debilitating surgery,
whereby the joint is removed and reimplanted 6 to 8 weeks after the
patient’s confinement to a hospital bed,” said Roger J. Pomerantz,
MD, President, Chief Executive Officer, and Chairman of ContraFect.
“PJIs are a completely underserved area of medicine, where no
randomized clinical trials have been completed. As the population
of the developed world ages, we must find a safe, effective and
minimally-invasive way to treat these infections or millions of
patients will continue to suffer. Based on promising activity we
have seen with exebacase in vitro, in vivo, and in compassionate
uses to date, we look forward to completing what could be the first
successful blinded and randomized trial in the field of PJIs.”
The Phase 1b/2 study of exebacase is a
randomized, double-blind, placebo-controlled two-part clinical
study to be conducted in France to assess the efficacy and safety
of exebacase in the setting of an arthroscopic DAIR procedure in
patients with chronic PJI of the knee due to S. aureus and/or CoNS.
Part 1 will evaluate the safety, PK, clinical outcomes, and
microbiologic response in patients through Day 42. Up to 2 dose
levels of intra-articularly administered exebacase in addition to
systemic antibiotics will be studied in up to 2 patient cohorts.
Part 2 will consist of a long-term follow-up study of safety and
efficacy parameters in patients who complete Part 1 of the study.
Follow-up assessments will be performed on Days 90, 180, 360 and
720.
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 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 was granted Breakthrough Therapy
designation by the FDA for the 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 ANSM approval, the CTA and
the clinical trial, statements made by Dr. Pomerantz, the conduct
of the Phase 1b/2 study, ContraFect’s ability to discover and
develop DLAs as new medical modalities for the treatment of
life-threatening, antibiotic-resistant infections, 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, without limitation, that ContraFect has and
expects to continue to incur significant losses, ContraFect’s need
for additional funding, which may not be available, 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, changes in
management may negatively affect ContraFect’s business and other
important risks detailed under the caption “Risk Factors” in
ContraFect's Quarterly Report on Form 10-Q for the quarter ended
September 30, 2022 and its other filings with the Securities and
Exchange Commission. Actual results may differ from those set forth
in the forward-looking statements. 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
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