ROCKVILLE, Md., June 25, 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, today announced that researchers at Cedars-Sinai Medical
Center (Cedars-Sinai) found that eradication of breath methane and
reduction of intestinal levels of the most common methanogenic
bacterium in the human gut (M. smithii) resulted in improved
insulin sensitivity by up to 50 percent, and a reduction in total
cholesterol and LDL cholesterol levels in pre-diabetic, obese human
subjects. The findings provide preliminary evidence that the
management of methane in the gut may lead to a new generation of
medicines for treating Type 2 diabetes and obesity, two morbidities
often linked together.
This Cedars-Sinai study, which was funded by the American
Diabetes Association (ADA), was the subject of a late breaking
poster presentation at the ADA's 74th Scientific Sessions recently
held in San Francisco. This
research examined the effects of methane-regulating treatments on
conditions such as Type 2 diabetes and obesity, which along with
constipation-predominant irritable bowel syndrome (C-IBS), are the
three conditions for which Synthetic Biologics has the right to
develop treatments under the exclusive license agreement with
Cedars-Sinai dated December 5, 2013.
The most clinically advanced of Synthetic Biologics' programs in
this area is the development of SYN-010, an oral treatment to
reduce the impact of methane producing organisms on C-IBS, with a
Phase II trial expected to start during the second half of
2014.
In the poster presented at ADA, lead researcher Ruchi Mathur, M.D., FRCP(C) of
Cedars-Sinai, along with other Cedars-Sinai researchers, including
Mark Pimentel, M.D., FRCP(C),
reported that eradication of M. smithii (as measured by the
surrogate of breath methane) in 8 of the 11 pre-diabetic, obese
subjects tested resulted in improvement in the subjects' metabolic
profiles after a 10 day course of antibiotics.
"Cedars-Sinai researchers have previously shown that the
presence of methane in the gut is associated with a slowing of
intestinal transit, which may also allow for increased time for
absorption of nutrients and enhanced energy harvest thus
contributing to a variety of diseases including C-IBS, diabetes and
obesity," noted Jeffrey Riley, Chief
Executive Officer of Synthetic Biologics.
Mr. Riley concluded, "The results from this new research provide
further exciting insight into the role of gut methane in various
metabolic diseases, including Type 2 diabetes and obesity. These
findings also support Synthetic Biologics' efforts to develop new
therapeutic agents, such as SYN-010, to manage the chronic symptoms
of C-IBS through gut methane depletion."
About SYN-010 Clinical Development
In December 2013, Synthetic
Biologics entered into worldwide exclusive license and option
agreements with Cedars-Sinai for the development of products for
therapeutic and prophylactic treatments for acute and chronic
diseases, such as C-IBS, Type 2 diabetes and obesity. Synthetic
Biologics will focus initially on the development of SYN-010, an
oral treatment to reduce the impact of methane producing organisms
on C-IBS. The Company initiated in
vivo/pharmacokinetic/pharmacodynamic studies in the first half
of 2014, and expects to initiate a Phase II clinical trial during
the second half of 2014 under an Investigational New Drug (IND)
application.
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 Synthetic Biologics'
intended development efforts and the effects of the
management of methane on Type 2 Diabetes and obesity. 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,
studies and those conducted by investigators, to be commenced or
completed on time or to achieve desired results or results
similar to those in the findings from the research project,
a failure of Synthetic Biologics' clinical trials to receive
anticipated funding, a failure of Synthetic Biologics' candidates
for the prevention and treatment of infectious 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, 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.
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SOURCE Synthetic Biologics, Inc.