ROCKVILLE, Md., April 1, 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 clinical data
supporting the development of SYN-004, the Company's candidate
therapy designed to degrade certain beta-lactam intravenous (IV)
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 and
secondary antibiotic-resistant infections, has been selected for
presentation during the 115th General Meeting of the
American Society of Microbiology (ASM2015) in New Orleans, LA on May
30-June 1.
A second poster featuring Synthetic Biologics' data will be
presented at ASM2015. These data support expanding the development
of therapeutics designed to protect the microbiome from all
beta-lactam antibiotics for the prevention of C. difficile
infection, beyond penicillins and cephalosporins. The schedule for
the two poster presentations will be as follows:
Title: Clinical Evaluation of SYN-004, an Oral
Beta-Lactamase Therapy for the Prevention of Antibiotic-Induced
Disruption of Intestinal Microflora
Authors: J.
Sliman, J. A. Bristol, S.
Hubert, O. Coughlin, J. Kokai-Kun,
A. Sloan, H. Whalen, T. Roberts, M. Schlosser, S. Connelly, P.
Koski, M. Kaleko; Synthetic Biologics, Inc., Rockville, MD
Date/Time: Monday, June 1,
2015, 10:45am - 12:00pm
(CT)
Poster Board Number: 953
Title: Development of Therapeutic Agents that Protect
the Colonic Microflora from All Beta-Lactam Antibiotics for the
Prevention of Clostridium difficile
Infection
Authors: S. Connelly1, T.
Parsley2, P. Koski1, M. Kaleko1;
1Synthetic Biologics, Inc., Rockville, MD, 2SynPhaGen, LLC,
Rockville, MD
Date/Time: Tuesday, June 2,
2015, 12:30pm - 1:45pm
(CT)
Poster Board Number: 2339
"Our microbiome-focused, C. difficile preventive therapy
candidate, SYN-004, continues to gain recognition and attention as
this clinical program moves into Phase 2 development," stated
Jeffrey Riley, Chief Executive
Officer of Synthetic Biologics. "We initiated a Phase 2a clinical
trial of SYN-004 in March, and anticipate initiating a Phase 2b
clinical trial 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
infectionsi and 30,000 C. difficile-related
deathsii in the United
States each year. Approximately 118 million doses of IV
beta-lactam antibioticsiii 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-004, continued recognition and attention of SYN-004,
anticipated timing of the initiation of the Phase 2b clinical
trial 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, 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.