ROCKVILLE, Md., March 30, 2015 /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 the initiation of a
Phase 2a clinical trial to evaluate the gastrointestinal (GI)
antibiotic-degrading effects and the safety of SYN-004, the
Company's investigational oral beta-lactamase enzyme designed to
protect the microbiome and prevent C. difficile infection
(CDI). C. difficile is the leading type of hospital acquired
infection and is frequently associated with intravenous (IV)
antibiotic treatment. Beta-lactam antibiotics are a mainstay in
hospital infection management, and include commonly used penicillin
and cephalosporin antibiotics, such as ceftriaxone.
"We are excited to start our Phase 2a trial of SYN-004 on
schedule. Synthetic Biologics believes SYN-004 holds the potential
to protect the microbiome from the damaging effects of antibiotics
and dramatically reduce C. difficile infections through
prevention vs. treatment," said Jeffrey
Riley, Chief Executive Officer of Synthetic Biologics. "We
anticipate reporting topline results from this Phase 2a clinical
trial during the second quarter of 2015, and initiating the Phase
2b clinical trial in the second half of this year."
The U.S. Centers for Disease Control and Prevention (CDC) has
categorized C. difficile as an "urgent public health
threat," and has stated the need for research to better understand
the role of normal gut bacteria. SYN-004 is intended to block the
unintended harmful effects of antibiotics within the GI tract and
maintain the natural balance of the gut microbiome, potentially
preventing the 1.1 million C. difficile
infectionsi and 30,000 C. difficile-related
deathsii in the United
States each year. During 2012, approximately 14 million U.S.
patients received approximately 118 million doses of IV beta-lactam
antibioticsiii that could be inactivated in the GI tract
by SYN-004.
The Phase 2a randomized, multi-center, open-label study is
expected to evaluate the ability of two different dose strengths of
SYN-004 to degrade residual IV ceftriaxone in the GI tract of up to
20 healthy participants with functioning ileostomies, without
affecting the concentrations of IV ceftriaxone in the bloodstream.
The study consists of two treatment phases for all participants: 1)
the administration of IV ceftriaxone alone, and 2) the
administration of one of two doses of oral SYN-004 and IV
ceftriaxone. Chyme samples will be collected from the participants
to measure the ability of SYN-004 to degrade the residual
antibiotic. Participants will be enrolled at up to four trial sites
located in the United States and
Canada.
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 gut microbiome from
intravenous (IV) antibiotics for the prevention of C.
difficile infection, an oral statin treatment to reduce the
impact of methane producing organisms on irritable bowel syndrome
with constipation (IBS-C), and in collaboration with Intrexon
Corporation (NYSE: XON), a monoclonal antibody combination for the
treatment of Pertussis. 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 potential of
SYN-004 to protect the microbiome from the damaging effects of
antibiotics and dramatically reduce C. difficile infections through
prevention vs. treatment, the anticipated timing of the
reporting of topline data from the Phase 2a clinical trial and the
timing of initiation of the Phase 2b clinical trial 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, 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: September 30, 2013.
iii 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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SOURCE Synthetic Biologics, Inc.