ROCKVILLE, Md., March 11, 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 that preclinical results
supporting the development of SYN-004, the Company's candidate
therapy designed to degrade intravenous (IV) antibiotics within the
gastrointestinal (GI) tract and maintain the natural balance of the
gut microbiome for the prevention of C. difficile infection,
will be presented during Digestive Disease Week® (DDW) 2015 in
Washington DC on May 16-19.
Synthetic Biologics' late-breaking abstract was accepted for
poster presentation and will be available for viewing at DDW in
Hall C at the Walter E. Washington Convention Center on
Tuesday, May 19, from 9:30 a.m. to 4:00 p.m. (EDT), as part of the
"DDW Late-Breaker Posters" session.
Title:
SYN-004, a Clinical Stage Oral Beta-Lactamase Therapy, Protects the
Intestinal Microflora from Antibiotic-Mediated Damage in Humanized
Pigs
Authors: Sheila Connelly1, Giovanni
Widmer2, Jean Mukherjee2; Kevin
Huynh2, J. Andrew Bristol1, Steven
Hubert1, Joseph Sliman1, Saul
Tzipori2, Michael
Kaleko1 1Synthetic Biologics, Inc.,
Rockville, MD; 2Tufts Cummings School of Veterinary
Medicine, North Grafton, MA
|
"We are pleased our microbiome-focused, C. difficile
preventive therapy candidate, SYN-004, continues to gain visibility
and recognition among our academic peers as this program advances
toward Phase 2 clinical trials," noted Jeffrey Riley, Chief Executive Officer of
Synthetic Biologics. "We are on schedule to initiate the Phase 2a
clinical trial of SYN-004 this quarter, with a Phase 2b clinical
trial anticipated to initiate during 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 infections[i] and
30,000 C. difficile-related deaths[ii] in the United States each year. Approximately 118
million doses of IV beta-lactam antibiotics[iii] that could be
inactivated in the GI tract by SYN-004, were administered to
approximately 14 million hospitalized U.S. patients during
2012.
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
constipation-predominant irritable bowel syndrome (C-IBS), 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 intended treatment
for SYN-0004, continued visibility and recognition of SYN-004,
anticipated timing of the Phase 2b clinical trial topline results
and the size of the market. 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 ability of SYN-004 to perform as expected, the results
of the clinical trials 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] 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.
Logo -
http://photos.prnewswire.com/prnh/20130522/MM19465LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/synthetic-biologics-syn-004-data-for-protection-of-microbiome-selected-for-late-breaking-poster-presentation-at-digestive-disease-week-2015-300048641.html
SOURCE Synthetic Biologics, Inc.