ROCKVILLE, Md., Sept. 7, 2014 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a biotechnology company developing
novel anti-infective biologic and drug programs targeting specific
pathogens that cause serious infections and diseases, announced
today preclinical data that further validate the Company's novel
approach to preventing Clostridium difficile (C. difficile).
The U.S. Centers for Disease Control has identified C.
difficile as an "urgent public health threat," and it has
surpassed MRSA as the number one hospital-acquired infection in
the United States. The data were
highlighted on September
6th at the 54th Interscience
Conference on Antimicrobial Agents and Chemotherapy (ICAAC), in
Washington, D.C.
Synthetic Biologics' Senior Vice President, Research &
Development, Mike Kaleko, M.D.,
Ph.D., presented a late-breaking poster demonstrating the broad
activity of its lead anti-infective candidate SYN-004 (P3A), as
well as a potential pipeline candidate, P4A, for C.
difficile prophylaxis. Both SYN-004 and P4A effectively
degraded a broad spectrum of commonly used intravenous (IV)
antibiotics that can lead to C. difficile infections,
including cephalosporins.
"We were honored to have the opportunity to present our novel
program for the prevention of C. difficile infection,
including both SYN-004 and P4A. SYN-004 is designed to protect the
gastrointestinal (GI) microflora – or gut microbiome – from the
effects of certain commonly used IV antibiotics, thereby preventing
C. difficile infection," said Jeffrey Riley, Chief Executive Officer of
Synthetic Biologics. "We are in the final stages of preparing the
Investigational New Drug (IND) application for SYN-004, with the
expectation of initiating Phase Ia and Ib clinical trials in the
fourth quarter of 2014, and a Phase II efficacy study in the first
half of 2015."
About C. difficile Infections
C. difficile is classified by the CDC as an "urgent
public health threat," given its high prevalence and resistance to
many drugs used to treat other infections. It affects 1.1 million
Americans and causes 30,000 deaths each year,[i],[ii]
adding an estimated four to seven hospitalization days per
patient[iii] and $8.2 billion in
overall annual hospital costs.[iv] C. difficile infections
are strongly associated with the use of IV antibiotics, which are
administered to more than 24 million Americans annually to prevent
or treat infections.[v] These powerful antibiotics can create a
harmful imbalance in the gastrointestinal tract by wiping out
helpful, "good" bacteria, and allowing C. difficile to grow
out-of-control, leading to severe diarrhea, damaging the colon, and
in some cases, death.[vi]
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology
company focused on the development of novel anti-infective biologic
and drug candidates targeting specific pathogens that cause serious
infections and diseases. The Company is developing an oral biologic
to protect the gastrointestinal microflora from the effects of IV
antibiotics for the prevention of Clostridium difficile (C.
difficile) infection, an oral treatment to reduce the impact of
methane producing organisms on constipation-predominant irritable
bowel syndrome (C-IBS), a series of monoclonal antibodies for the
treatment of Pertussis and Acinetobacter infections, and a
biologic targeted at the prevention and treatment of a root cause
of a subset of IBS. In addition, the Company is developing an 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 design of SYN -004,
Synthetic Biologics' expected initiation
of Phase Ia and Ib clinical trials in the fourth
quarter of 2014, and a Phase II efficacy study in the first half of
2015 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 additional clinical studies and results not meeting
expectations, the inability to commence and complete clinical
trials when anticipated 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] (APIC) National Prevalence Study of Clostridium
difficile in U.S. Healthcare Facilities. November 11,
2008.http://hospitalacquiredinfections.blogspot.com/2008/12/november-11-2008-association-for.html
Accessed: September 30, 2013.
[iv] Agency for Healthcare Research and Quality. Healthcare and
Cost Utilization Project. Statistical Brief #125. Clostridium
difficile Infections (CDI) in Hospital Stays, 2009. January 2012.
http://www.hcup-us.ahrq.gov/reports/statbriefs/sb124.pdf Accessed:
October 1, 2013.
[v] 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.
[vi] Committee to Reduce Infection Deaths Web site
http://www.hospitalinfection.org/preventing_cdiff.shtml Accessed:
September 30, 2013.
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SOURCE Synthetic Biologics, Inc.