ROCKVILLE, Md., Sept. 2, 2014 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a developer of novel
anti-infective biologic and drug candidates targeting specific
pathogens that cause serious infections and diseases, announced
today positive results from its final preclinical toxicology study
of SYN-004. Per U.S. Food and Drug Administration (FDA) guidance,
this bridging study was required to move the Company's lead
anti-infective, second-generation product candidate designed to
prevent the devastating effects of Clostridium difficile (C.
difficile), toward the clinic.
The Company is in the final stages of preparing its SYN-004 IND
application for submission to the FDA, 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.
"As the need for a preventative for C. difficile
infections continues to increase globally, moving our SYN-004
program toward the clinic is more important than ever," stated
Jeffrey Riley, Chief Executive
Officer of Synthetic Biologics. "SYN-004 is unique from other C.
difficile preventative approaches in development, as it is
designed to protect and maintain the microbiome, and prevent the
proliferation and devastating effects of C. difficile
infections. Research continues to demonstrate that protection of
the microbiome also plays an increasingly important role in the
prevention of a variety of GI, metabolic and CNS disorders."
Mr. Riley concluded, "In addition, SYN-004 is provided only when
necessary – as a patient receives IV antibiotics and is at greatest
risk of developing C. difficile. Synthetic Biologics'
point-of-care preventative approach contrasts significantly with
approaches that require mass vaccination."
In the preclinical toxicology study, oral SYN-004 was safe and
well tolerated in a canine model over a 28-day dosing period,
showing no evidence of toxicity to date at high, repeated doses
exceeding those anticipated to be used during human clinical
development. These data support Synthetic Biologics efforts to move
into clinical development.
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,1,2 adding
an estimated four to seven hospitalization days per
patient3 and $8.2 billion
in overall annual hospital costs.4 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.5 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.6
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 intended effects
and potential impact of SYN-004, the timing of the IND filing,
initiation of the Phase Ia and Ib clinical studies, the initiation
of Phase II efficacy study and the expected size of the market for
C. diff therapeutics. 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, our inability to
timely commence or complete the clinical trials consistent with our
current expectations and otherwise demonstrate the ability of
SYN-004 to have a significant impact on mitigating the effects of
C. difficile, our ability to successfully manufacture cGMP product,
receive regulatory approvals for or to commercialize a new product
candidate to prevent C. diff infection 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.
1 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.
2 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.
3 (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.
4 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.
5 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.
6 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.