ROCKVILLE, Md., Nov. 24, 2014 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a developer of pathogen-specific
therapies for serious infections and diseases, with a focus on
protecting the microbiome, today announced that its Investigational
New Drug (IND) application which was submitted to the U.S. Food and
Drug Administration (FDA) in October will be proceeding into
clinical trials for the development of the Company's oral
beta-lactamase enzyme SYN-004 for the prevention of Clostridium
difficile (C. difficile) infection (CDI), antibiotic-associated
diarrhea (AAD) and secondary infections with healthcare-acquired,
drug-resistant pathogens in patients receiving intravenous (IV)
beta-lactam antibiotic therapy. Synthetic Biologics plans to begin
Phase 1a and 1b clinical trials shortly, with topline data expected
to be reported before year-end.
"We are pleased the FDA completed the 30-day review of our IND
and to be initiating clinical trials of the first potential
point-of-care preventative therapy for C. difficile, the
CDC's top-ranking public health threat," said Jeffrey Riley, Chief Executive Officer of
Synthetic Biologics. "Taking immediate and aggressive action to
develop a therapy that can prevent C. difficile before it
starts is critical in addressing this pervasive and
life-threatening infection, and IND activation for SYN-004 is a key
step toward the development and eventual commercialization of
therapy to protect the millions of at risk U.S. patients."
C. difficile is a widespread infection that occurs mostly
in people who have had recent medical care with IV antibiotics.
These antibiotics can create a harmful imbalance in the gut
microbiome by killing "good" bacteria, giving C. difficile a
chance to multiply and cause diarrhea, which can lead to
dehydration, fever, abdominal pain, cramping, nausea, colitis, and
even death. In all, 24 million Americans receive IV antibiotics
annuallyi, and the Company believes there is currently
no vaccine or drug approved for the prevention of C.
difficile infection.
SYN-004 is Synthetic Biologics' oral drug candidate designed to
be the first and only prophylactic treatment intended to prevent
the development of C. difficile infection, by binding with
and neutralizing certain common IV beta-lactam antibiotics in the
gut. SYN-004 is intended to block the unintended harmful effects of
antibiotics within the gastrointestinal (GI) tract, maintaining the
natural balance of the bacterial flora (gut microbiome),
potentially preventing the 1.1 million C. difficile
infectionsii and 30,000 C. difficile-related
deathsiii in the U.S. each year.
Mr. Riley added, "In addition to antibiotics being a key trigger
in the development of C. difficile infection, research
continues to point to the fact that disruption of the gut
microbiome due to antibiotic usage, as well as the steady rise in
antibiotic-resistant superbugs, are causative factors for a variety
of GI, CNS and metabolic disorders, including obesity and diabetes.
SYN-004 may be the solution."
Synthetic Biologics has met each milestone for its C.
difficile program leading up to the IND submission to the
agency. Clinical drug manufacturing of SYN-004 under cGMP
guidelines to support Synthetic Biologics' planned Phase 1 and 2
clinical trials was completed on time to support the IND submission
and clinical trial initiation. Most recently, the U.S. Patent and
Trademark Office issued a Notice of Allowance for the first
composition of matter patent application directly pertaining to
SYN-004 in the U.S., which carries a patent term to at least
2031.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical-stage
biotechnology company developing pathogen-specific therapies for
serious infections and diseases, with a focus on protecting the
microbiome. The Company is developing an oral biologic to protect
the gastrointestinal (GI) microflora from the effects of
intravenous (IV) antibiotics for the prevention of C.
difficile infection, an oral treatment to reduce the impact of
methane producing organisms on constipation-predominant irritable
bowel syndrome (C-IBS) and a monoclonal antibody combination for
the treatment of Pertussis being developed in collaboration with
Intrexon Corporation (NYSE: XON). In addition, the Company is
developing a Phase 2 oral estriol drug for the treatment of
relapsing-remitting multiple sclerosis (MS) and cognitive
dysfunction in MS. For more information, please visit Synthetic
Biologics' website at www.syntheticbiologics.com.
This release includes forward-looking statements on Synthetic
Biologics' current expectations and projections about future
events. 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. These statements are based
upon current beliefs, expectations and assumptions and are subject
to a number of risks and uncertainties, many of which are difficult
to predict and include statements regarding the anticipated timing
of the Synthetic Biologics' clinical trials and data reports,
intended benefits to be achieved from use of SYN-004, including the
potential prevention of C. difficile infections, and the potential
market for SYN-004. The forward-looking statements are subject to
risks and uncertainties that could cause actual results to differ
materially from those set forth or implied by any forward-looking
statements. Important factors that could cause actual results to
differ materially from those reflected in Synthetic Biologics'
forward-looking statements include, among others, a failure to
receive the necessary regulatory approvals for commercialization of
Synthetic Biologics' therapeutics, a failure of Synthetic
Biologics' clinical trials, and those conducted by investigators,
to be commenced or completed on time or to achieve desired results,
a failure of Synthetic Biologics' clinical trials to receive
anticipated funding, a failure of Synthetic Biologics' products for
the prevention and treatment of diseases to be successfully
developed or commercialized, Synthetic Biologics' inability to
maintain its licensing agreements, or a failure by Synthetic
Biologics or its strategic partners to successfully commercialize
products and other factors described in Synthetic Biologics' report
on Form 10-K for the year ended December 31,
2013 and any other filings with the SEC. 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.
i
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This information is
an estimate derived from the use of information under license from
the following IMS Health Incorporated information service: CDM
Hospital database for full year 2012. IMS expressly reserves all
rights, including rights of copying, distribution and
republication.
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ii
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This information is
an estimate derived from the use of information under license from
the following IMS Health Incorporated information service: CDM
Hospital database for full year 2012. IMS expressly reserves all
rights, including rights of copying, distribution and
republication.
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iii
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U.S. Department of
Health & Human Services. Agency for Healthcare Research and
Quality. January 25, 2012. http://www.ahrq.gov/news/nn/nn012512.htm
Accessed: September 30, 2013.
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SOURCE Synthetic Biologics, Inc.