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 that it has initiated an expanded access program to
provide exebacase for the treatment of persistent bacteremia caused
by methicillin-resistant Staphylococcus aureus (MRSA) in COVID-19
patients. Exebacase has been granted Breakthrough Therapy
designation for the treatment of MRSA bloodstream infections by the
U.S. Food and Drug Administration (FDA). The Company is providing
expanded access to exebacase under a treatment protocol available
to clinical sites participating in the ongoing Phase 3 study, which
enables physicians to use exebacase to treat severely ill COVID-19
patients with persistent MRSA bacteremia, despite treatment with
standard of care antibiotics. These patients who are hospitalized
with COVID-19 may now have access to exebacase since they are not
eligible to participate in the ongoing Phase 3 study. Based on the
results of the completed Phase 2 study, the Company believes that
treatment with exebacase in addition to anti-staphylococcal
antibiotics has the potential to improve clinical outcomes for many
COVID-19 patients who have persistent MRSA bacteremia. More
information about the program is available at
www.clinicaltrials.gov (NCT04597242).
Roger J. Pomerantz, M.D., F.A.C.P., President,
Chief Executive Officer, and Chairman of ContraFect said, “As a
company dedicated to defeating serious infectious diseases, it is
our responsibility to actively attempt to help severely ill
patients with COVID-19. Exebacase has the potential to treat MRSA
superinfections in patients infected with COVID-19, a significant
cause of severe disease. This enduring crisis, in addition to the
upcoming flu season, demands that our potential breakthrough
therapy be accessible to all patients who have life-threatening
MRSA bacteremia, and we are hopeful that exebacase could have a
favorable impact on patient outcomes.”
Respiratory viral infections, such as influenza,
SARS and MERS, are commonly associated with secondary infections,
or superinfections, by opportunistic pathogens. During previous
influenza epidemics, including the 1918-19 “Spanish Flu” pandemic,
the majority of deaths likely resulted directly from secondary
bacterial pneumonia1,2. While there is currently limited data,
secondary bacterial infections have been noted in China over the
course of the COVID-19 pandemic with up to 50% of patients who died
experiencing a secondary infection3,4. This potential role of
bacterial superinfections in the clinical outcomes of COVID-19
patients has been recently recognized as an emerging issue in the
U.S.5,6. Staph aureus is one of the most common pathogenic causes
of secondary bacterial infections in patients suffering from severe
respiratory viral infections.
This represents another compassionate use
program for exebacase. ContraFect continues to provide early access
to exebacase to individual named patients with chronic
post-operative prosthetic joint infections (PJIs) under Temporary
Authorizations for Use from the French National Agency for
Medicines and Health Products Safety obtained by Dr. Tristan Ferry
at the Hôpital de la Croix Rousse in Lyon, France. Staphylococcal
PJIs pose significant treatment challenges due to biofilm
formation, which renders conventional antibiotics ineffective and
necessitates surgical removal and replacement of the prosthetic
joint. There are medicinal therapies approved by FDA for the
treatment of PJIs and surgical intervention (e.g. removal and
replacement of the infected joint) is the current standard of care.
Through this compassionate use program, ContraFect is able to gain
an early assessment of the safety of intra-articular administration
of exebacase and potential early signs of efficacy of exebacase as
a potential therapeutic agent for PJIs.
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 standard-of-care (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 mean length
of hospital stay and meaningful reductions in hospital readmission
rates. Exebacase is currently being studied in the Phase 3 DISRUPT
(Direct Lysis of Staph aureus Resistant Pathogen Trial) 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. Exebacase was
licensed from The Rockefeller University and is being developed at
ContraFect.
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 are randomized 2:1 to receive either
exebacase or placebo, with all patients receiving SOC antibiotics.
The primary efficacy endpoint of the study is clinical response at
day 14 in patients with MRSA bacteremia, including right-sided
endocarditis. Secondary endpoints 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 later timepoints. The company plans to
conduct an interim futility analysis following the enrollment of
approximately 60% of the study population.
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, including right-sided
endocarditis, when used in addition to SOC 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,
whether the Company will initiate the expanded access program and
provide expanded access to exebacase for COVID-19 patients, whether
physicians will use exebacase to treat COVID-19 patients, whether
hospitalized COVID-19 patients will have access to exebacase,
whether treatment with exebacase in addition to anti-staphylococcal
antibiotics has the potential to improve clinical outcomes for many
COVID-19 patients who have persistent MRSA bacteremia, statements
made by Dr. Pomerantz, statements related to secondary infections
and their cited references, whether Staph aureus is one of the most
common pathogenic causes of secondary bacterial infections in
patients with severe respiratory viral infections, whether the
Company continues to provide early access to exebacase to
individual named patients with PJIs under ATUs, whether ContraFect
will gain an early assessment of the safety of intra-articular
administration of exebacase and early signs of efficacy of
exebacase as a therapeutic agent, whether exebacase has the
potential to be a first-in-class treatment for exebacase, whether
ContraFect will 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 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 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.
References:
- David M. Morens,
Jeffery K. Taubenberger, and Anthony S. Fauci (2008). Predominant
Role of Bacterial Pneumonia as a Cause of Death in Pandemic
Influenza: Implications for Pandemic Influenza Preparedness.
Journal of Infectious Diseases 198(7): 962–970.
- Denise E. Morris,
David W. Cleary and Stuart C. Clarke (2017). Secondary Bacterial
Infections Associated with Influenza Pandemics. Frontiers in
Microbiology, June 2017, Volume 8, Article 1041.
- Fei Zhou, Ting Yu,
Ronghui Du, et al (2020). Clinical course and risk factors for
mortality of adult inpatients with COVID-19 in Wuhan, China: a
retrospective cohort study. The Lancet. Published online March 9,
2020 https://doi.org/10.1016/S0140-6736(20)30566-3.
- Xiaobo Yang, Yuan
Yu, Jiqian Xu, et al (2020). Clinical course and outcomes of
critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China:
a single-centered, retrospective, observational study. The Lancet.
Published Online February 21, 2020
https://doi.org/10.1016/S2213-2600(20)30079-5.
- Kenneth Thorpe
(2020). Industry Voices—Another enemy emerges in the COVID-19
fight: Antibiotic-resistant bugs. Fierce Healthcare
https://www.fiercehealthcare.com/hospitals-health-systems/industry-voices-another-enemy-emerges-covid-19-fight-antibiotic-resistant
- Dr. Julie
Gerberding (2020). Antibiotic resistance: the hidden threat lurking
behind Covid-19. STAT
https://www.statnews.com/2020/03/23/antibiotic-resistance-hidden-threat-lurking-behind-covid-19/
Investor Relations
Contacts
Michael MessingerContraFect
Corporationmmessinger@contrafect.com
Carlo Tanzi, Ph.D.Kendall Investor
Relationsctanzi@kendallinvestorrelations.com
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