ROCKVILLE, Md., Sept. 21, 2015 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a clinical-stage company focused
on developing therapeutics to protect the microbiome while
targeting pathogen-specific diseases, presented data from its novel
SYN-004 program that demonstrated SYN-004 protected the gut
microbiome from damage often caused by the intravenous (IV)
beta-lactam antibiotic, ceftriaxone, in a pilot study of humanized
pigs. The data were presented yesterday in a late-breaker oral
presentation at the 2015 Interscience Conference of Antimicrobial
Agents and Chemotherapy and International Congress of Chemotherapy
and Infection joint meeting (ICAAC/ICC 2015) in San Diego, CA.
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SYN-004 is the Company's candidate therapy, currently in Phase 2
clinical trials, that is designed to degrade certain IV beta-lactam
antibiotics within the gastrointestinal (GI) tract and maintain the
natural balance of the gut microbiome for the prevention of C.
difficile infection, antibiotic-associated diarrhea (AAD) and
secondary antibiotic-resistant infections. C. difficile is
frequently associated with IV antibiotic treatment and is the
leading type of hospital acquired infection accounting for more
than 1.1 million infectionsi and 30,000 related
deathsii each year in the
United States.
Beta-lactam antibiotics are a mainstay of hospital infection
management and include commonly used penicillin and cephalosporin
antibiotics such as ceftriaxone. However, antibiotics may
unintentionally disrupt the natural balance of the gut microbiome,
potentially leading to the development of C. difficile
infection.
The Company's presentation, delivered by Vice President,
Research, Sheila Connelly, Ph.D.,
summarized the microbiome analyses from the pilot study in which
the pigs' colons were populated with human stool, as follows:
- Of significant importance, in the cohort that was administered
oral SYN-004 plus IV ceftriaxone, the natural balance of bacteria
in the gut microbiome was maintained.
- In contrast, in the cohort administered IV ceftriaxone alone,
damage occurred and the natural balance of the gut microbiome was
altered.
"Showcasing positive data from our lead microbiome program this
year at ICAAC/ICC is further encouragement that SYN-004 has the
potential to become the first prophylactic therapy designed to
protect the gut microbiome from the unintended damage caused by IV
antibiotics, including C. difficile infection and
antibiotic-associated diarrhea," stated Jeff Riley, Chief Executive Officer of Synthetic
Biologics. "We continue to move SYN-004 through the clinical
pathway and look forward to initiating our SYN-004 Phase 2b
proof-of-concept trial expected later this quarter."
About Synthetic Biologics, Inc.
Synthetic Biologics,
Inc. (NYSE MKT: SYN) is a microbiome-focused, clinical-stage
company developing therapeutics to protect the microbiome while
targeting pathogen-specific diseases. The Company's lead candidates
in Phase 2 development include SYN-004 which is designed to protect
the gut microbiome from the effects of certain commonly used
intravenous (IV) antibiotics for the prevention of C.
difficile infection and antibiotic-associated diarrhea (AAD),
and SYN-010 which is intended to reduce the impact of methane
producing organisms in the gut microbiome to treat the underlying
cause of irritable bowel syndrome with constipation (IBS-C). 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, and in collaboration with Intrexon
Corporation (NYSE: XON), a monoclonal antibody combination for the
treatment of Pertussis and biotherapeutics for the treatment of
phenylketonuria (PKU). 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 design of SYN-004,
the potential for SYN-004 to become the first prophylactic
therapy designed to protect the gut microbiome from the
unintended damage caused by IV antibiotics, the continued clinical
pathway for SYN-004 and the timing of the Phase 2b proof-of-concept
clinical trial. 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, the additional clinical studies and results not meeting
expectations, the inability to commence and complete clinical
trials when expected and other factors described in Synthetic
Biologics' report on Form 10-K for the year ended December 31, 2014 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 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.
ii 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: June 7. 2015.
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SOURCE Synthetic Biologics, Inc.