ROCKVILLE, Md., Oct. 6, 2016 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a clinical stage company focused
on developing therapeutics to protect the gut microbiome while
targeting pathogen-specific diseases, announced today it has been
awarded a contract by the Centers for Disease Control and
Prevention (CDC). The award will support research conducted during
the Company's ongoing randomized, placebo-controlled Phase 2b
proof-of-concept clinical study of SYN-004 (ribaxamase), designed
to protect the gut microbiome from the unintended effects of
certain commonly used intravenous (IV) beta-lactam antibiotics for
the prevention of C. difficile infection (CDI),
antibiotic-associated diarrhea (AAD) and the emergence of
antibiotic-resistant organisms.
"Antibiotics are life-saving medicines, but they also can
disrupt a person's microbiome and increase the risk for
drug-resistant infections," said Dr. Clifford McDonald, Associate Director of Science
for CDC's Division of Healthcare Quality Promotion. "To protect
people, their microbiomes, and the effectiveness of antibiotics,
this project is an example of applied research that has the
potential to produce innovative public health approaches to better
combat antibiotic resistance."
The contract, awarded through the CDC's Advanced and Innovative
Solutions to Improve Public Health Broad Agency Announcement (BAA)
2016-N-17812, will support CDC's efforts to assess how selective
pressure from IV antibiotics may lead to the emergence of
antibiotic resistance in the gut microbiome. The funding will also
support research to evaluate ribaxamase's ability to reduce
selective pressure associated with the emergence of
antibiotic-resistant organisms in the gut microbiomes of patients
enrolled in the Company's ongoing Phase 2b clinical trial. The
Company will examine DNA isolated from longitudinal samples
obtained during the clinical trial and look for changes to the
patient's gut resistome, specifically examining for alterations in
the presence and/or abundance of antibiotic resistance genes.
"Synthetic Biologics is proud to have the support of the U.S.
Government in its efforts to study the role of antibiotics in
mediating resistance in the gut microbiome," said Jeffrey Riley, President and Chief Executive
Officer. "Ribaxamase's strategy of degrading certain IV beta-lactam
antibiotics before they are excreted into the GI tract has the
potential to protect the gut microbiome from disruption by these
antibiotics without inhibiting their ability to fight primary
infections as well as mitigate conditions conducive to
antibiotic-resistance development. We look forward to our
collaboration with CDC and to furthering their initiative to assess
and address rising global concerns for the proliferation of
antibiotic resistance."
About the Centers for Disease Control and Prevention
(CDC)
The Centers for Disease Control and Prevention (CDC) serves as
the national focus for developing and applying disease prevention
and control, environmental health, and health promotion and health
education activities designed to improve the health of the people
of the United States. As the
nation's health protection agency, CDC saves lives and protects
people from health threats. To accomplish its mission, CDC conducts
critical science and provides health information that protects our
nation against expensive and dangerous health threats, and responds
when these arise.
About SYN-004 (ribaxamase) and the Ongoing Phase 2b
Study
SYN-004 (ribaxamase) is a first-in-class oral enzyme designed to
degrade certain IV beta-lactam antibiotics within the GI tract and
maintain the natural balance of the gut microbiome for the
prevention of CDI, AAD and the emergence of antibiotic-resistant
organisms. The ongoing Phase 2b proof-of-concept clinical trial is
intended to evaluate the effectiveness of ribaxamase to prevent the
onset of C. difficile infection (CDI), C. difficile
associated diarrhea (CDAD), antibiotic-associated diarrhea (AAD)
and the emergence of antibiotic-resistant organisms in patients
hospitalized with a lower respiratory infection and receiving
intravenous (IV) ceftriaxone. The Company anticipates announcing
top-results from this study during the first quarter of 2017. To
access the ribaxamase mechanism of action video on Synthetic
Biologics' website, please click here.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical stage
company developing therapeutics to protect the gut microbiome while
targeting pathogen-specific diseases. The Company's lead candidates
poised for Phase 3 development are: (1) SYN-010 which is intended
to reduce the impact of methane producing organisms in the gut
microbiome to treat an underlying cause of irritable bowel syndrome
with constipation (IBS-C), and (2) SYN-004 (ribaxamase) which is
designed to protect the gut microbiome from the effects of certain
commonly used intravenous (IV) beta-lactam antibiotics for the
prevention of C. difficile infection, antibiotic-associated
diarrhea (AAD) and the emergence of antibiotic-resistant organisms.
The Company is also developing preclinical stage monoclonal
antibody therapies for the prevention and treatment of pertussis
and novel discovery stage biotherapeutics for the treatment of
phenylketonuria (PKU). For more information, please visit Synthetic
Biologics' website at
www.syntheticbiologics.com.
This release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of
1995. In some cases forward-looking statements can be
identified by terminology such as "may," "should," "potential,"
"continue," "expects," "anticipates," "intends," "plans,"
"believes," "estimates," and similar expressions, and include
statements regarding the potential of Ribaxamase to
protect the gut microbiome from disruption by these antibiotics
without inhibiting their ability to fight primary infections as
well as mitigate conditions conducive to antibiotic-resistance
development, the potential of the project to produce
innovative public health approaches to better combat antibiotic
resistance and the intended results to be achieved by use of
SYN-010 and SYN-004. These forward-looking
statements are based on management's expectations and
assumptions as of the date of this press release and are subject to
a number of risks and uncertainties, many of which are difficult to
predict and could cause actual results to differ
materially from current expectations and assumptions from those set
forth or implied by any forward-looking statements. Important
factors that could cause actual results to differ materially from
current expectations include, among others, Synthetic
Biologics' product candidates demonstrating safety and
effectiveness, as well as results that are consistent with prior
results, Synthetic Biologics' ability to initiate clinical trials
and if initiated, to complete them on time and achieve desired
results and benefits, Synthetic Biologics ability to
successfully design a protocol and a corresponding
statistical analysis plan to support the execution of the first
pivotal clinical trial for SYN-010, Synthetic Biologics'
clinical trials continuing enrollment as expected, Synthetic
Biologics' ability to obtain regulatory approvals for
commercialization of product candidates or to comply with ongoing
regulatory requirements, regulatory limitations relating to
Synthetic Biologics' ability to promote or commercialize its
product candidates for specific indications, acceptance of its
product candidates in the marketplace and the successful
development, marketing or sale of Synthetic Biologics' products
by competitors that render Synthetic Biologics' products
obsolete or non-competitive, Synthetic Biologics' ability to
maintain its license agreements, the continued maintenance and
growth of Synthetic Biologics' patent estate, Synthetic
Biologics becoming and remaining profitable, Synthetic
Biologics' ability to establish and maintain
collaborations, Synthetic Biologics' ability to obtain
or maintain the capital or grants necessary to fund its research
and development activities, a loss of any of Synthetic
Biologics' key scientists or management personnel, and
other factors described in Synthetic Biologics' Annual Report on
Form 10-K for the year ended December 31,
2015 and its other filings with the SEC, including
subsequent periodic reports on Forms 10-Q and 8-K. The information
in this release is provided only as of the date of this release,
and Synthetic Biologics undertakes no obligation to update any
forward-looking statements contained in this release on account of
new information, future events, or otherwise, except as required by
law.
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SOURCE Synthetic Biologics, Inc.