ROCKVILLE, Md., May 18, 2015 /PRNewswire/ -- Synthetic Biologics,
Inc. (NYSE MKT: SYN), a clinical-stage company focused on
developing therapeutics to protect the microbiome while targeting
pathogen-specific diseases, announced that preclinical results
supporting the development of SYN-010, the Company's candidate
therapy to reduce the impact of methane producing organisms on
irritable bowel syndrome with constipation (IBS-C),
were presented in a poster at Digestive Disease Week® (DDW)
2015 in Washington DC today. The
research was sponsored by Synthetic Biologics and performed at
Cedars-Sinai under the direction of Mark
Pimentel, M.D., FRCP(C), Director of Cedars-Sinai's GI
Motility Program and Laboratory, and Chairman of Synthetic
Biologics' IBS-C Clinical Advisory Board.
The "Lovastatin Improves Stool Form in Methanobrevibacter
smithii Colonized Rats with Constipation" poster summarized
preclinical efficacy data that support advancing Synthetic
Biologics' novel SYN-010, toward the clinic. The poster presented
key data from a rat model, which confirmed findings from previous
studies conducted by Dr. Pimentel, with the following
conclusions:
- Lovastatin reduced Methanobrevibacter smithii (M.
smithii) levels in the ileum (but not other intestinal
segments) of rats administered a high-fat diet; and
- Lovastatin improved stool water content in these rats.
"The data suggest that SYN-010 has therapeutic potential to
diminish the production of methane in the gut, treating the cause
of IBS-C, not just the symptoms," said Dr. Mark Pimentel.
"The presentation at the DDW meeting highlighted the therapeutic
potential of SYN-010 for IBS-C," stated Jeffrey Riley, Chief Executive Officer for
Synthetic Biologics. "This research, along with the fact that
SYN-010 is a new modified-release formulation of a widely
prescribed statin drug, provides a strong body of evidence as
Synthetic Biologics seeks to move our IBS-C program into a Phase 2
clinical trial during the second quarter of this year, with topline
results anticipated to follow during the second half of this
year."
Dr. Pimentel led the investigational team at Cedars-Sinai whose
discoveries established the foundation of Synthetic Biologics'
IBS-C program. SYN-010 is a proprietary modified-release
formulation of the classic statin, Lovastatin, that is optimal for
reducing methane-production by certain microorganisms (M.
smithii) in the gut while minimizing disruption to the
microbiome. Methane produced by M. smithii is perceived as
the underlying cause of bloating, pain and constipation associated
with IBS-C, and may contribute to the pathology of other diseases.
SYN-010 is intended to act primarily in the intestinal lumen while
avoiding systemic absorption, thereby targeting the cause of IBS-C,
not just the symptoms.
According to reports published by The International Foundation
for Functional Gastrointestinal Disorders (IFFGD), IBS affects an
estimated 10 to 15 percent of the population, or as many as 40
million Americans. The illness affects both men and women; however,
two-thirds of diagnosed sufferers are women. The onset of IBS can
begin anytime from adolescence to adulthood. It has been reported
that up to one-third of all IBS patients have IBS-C. Current Food
and Drug Administration (FDA)-approved therapies for the treatment
of IBS-C include AMITIZA® (lubiprostone) and
LINZESS® (linaclotide), and along with prescription and
over-the-counter laxatives, provide patients with symptomatic
relief and do not treat the underlying cause of bloating, pain and
constipation associated with IBS-C.
Synthetic Biologics anticipates a 505(b)(2) regulatory pathway
for SYN-010 which is designed to reduce the impact of methane
producing organisms on IBS-C. An extensive portfolio of granted use
patents and pending applications for SYN-010 has been licensed by
Cedars-Sinai to the Company. Additional worldwide patent filings
covering composition of matter claims, which were filed by
Cedars-Sinai in 2014 and licensed to Synthetic Biologics, could
extend patent protection of SYN-010 to 2035.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical-stage
company focused on developing therapeutics to protect the
microbiome while targeting pathogen-specific diseases. The Company
is developing an oral biologic to protect the gut microbiome from
intravenous (IV) antibiotics for the prevention of C.
difficile infection and an oral statin treatment to reduce the
impact of methane producing organisms on irritable bowel syndrome
with constipation (IBS-C). In addition, the Company is developing a
monoclonal antibody combination for the treatment of Pertussis in
collaboration with Intrexon Corporation (NYSE: XON), and 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.
AMITIZA® is a registered trademark of Sucampo AG, and
used under license by Takeda Pharmaceuticals America, Inc.
LINZESS® is a registered trademark of Actavis, Inc.
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 therapeutic
potential for SYN-010, intended treatment for SYN-010, the
potential market for SYN 010,, anticipated timing of the Phase 2
clinical trial and topline results, and the anticipated 505(b)(2)
regulatory pathway for SYN-010. 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-010 to perform as expected 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.
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SOURCE Synthetic Biologics, Inc.