ROCKVILLE, Md., June 29, 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, reported the initiation of a
Phase 2 clinical trial of its proprietary SYN-010 for the treatment
of irritable bowel syndrome with constipation (IBS-C). This is a
placebo-controlled study to evaluate the ability of two dose
strengths of SYN-010 to reduce the production of methane in breath
methane-positive patients with IBS-C. Breath methane is strongly
associated with constipation in IBS-C and higher methane levels are
proportional to constipation severity.
IBS affects an estimated 10 to 15 percent of the population, or
as many as 45 million people in North America[i]. The illness
affects both men and women; however, two-thirds of diagnosed
sufferers are women. It has been reported that up to 20 percent of
all IBS patients have IBS-C. Current U.S. Food and Drug
Administration (FDA)-approved therapies for the treatment of IBS-C
include AMITIZA® (lubiprostone) and LINZESS®
(linaclotide), and prescription and over-the-counter laxatives.
These products provide patients with temporary symptomatic relief,
but do not treat the underlying cause of pain, bloating and
constipation associated with IBS-C.
SYN-010 is a proprietary, modified-release formulation of the
classic statin, lovastatin, that is intended to reduce 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 pain,
bloating, and constipation associated with IBS-C. SYN-010 is intended to act primarily in
the intestinal lumen while avoiding systemic absorption, thereby
targeting the major cause of IBS-C, not just the symptoms. To
access the SYN-010 mechanism of action video on Synthetic
Biologics' website, please click here.
"Initiating this Phase 2 clinical trial is an important first
step to moving Synthetic Biologics' IBS-C program through the
clinic," stated Jeffrey Riley, Chief
Executive Officer of Synthetic Biologics. "Patients who complete
this first Phase 2 clinical trial of SYN-010, may enroll in a
second, SYN-010 only, Phase 2 extension clinical trial that will
evaluate the ability of SYN-010 to sustain the reduction in breath
methane levels. We anticipate initiating the second Phase 2 trial
and reporting topline results from the first Phase 2 clinical trial
during the second half of 2015."
This Phase 2, randomized, double-blind, parallel-group,
placebo-controlled, multi-dose study is expected to be conducted at
multiple centers in the United
States. The primary objective of this study is to evaluate
the change from baseline in breath methane, as determined by a
lactulose breath test, in methane-positive patients with IBS-C
after seven days of treatment with one of two formulations of
SYN-010 compared with placebo. Approximately 60 patients will be
enrolled and randomly assigned in a 1:1:1 ratio to one of three
groups, including two different SYN-010 dose groups and a placebo
group. Patients are scheduled to receive single oral doses of
SYN-010 each day for 28 days.
Mark Pimentel, M.D., FRCP(C),
Director of the GI Motility Program and Laboratory at Cedars-Sinai,
and lead investigator of the team whose pioneering discoveries
established the foundation of Synthetic Biologics' IBS-C program,
stated "With up to 9 million people suffering from IBS-C in the
U.S., the development of SYN-010 has an opportunity to address a
significant unmet medical need. Current treatments are focused on
relieving symptoms, whereas SYN-010 has therapeutic potential to
diminish the production of methane in the gut, treating a major
cause of IBS-C, not just the symptoms."
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. A 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 [two Phase 2a studies ongoing] and an oral
statin treatment to reduce the impact of methane producing
organisms on irritable bowel syndrome with constipation (IBS-C)
[Phase 2 study ongoing]. 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 Ironwood
Pharmaceuticals, 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 potential of
SYN-010 to reduce methane production for the treatment of IBS-C and
address an unmet need, the anticipated timing of the
reporting of topline data from the initial Phase 2 clinical trial
and the timing of initiation of a second Phase 2 clinical trial
and the potential market 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, a failure to receive the necessary regulatory approvals for
commercialization of Synthetic Biologics' therapeutics, a failure
of Synthetic Biologics' clinical trials, and those conducted by
investigators, to be commenced or completed on time or to achieve
desired results, a failure of Synthetic Biologics' clinical trials
to receive anticipated funding, a failure of Synthetic Biologics'
products for the prevention and treatment of 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, 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] The International Foundation for Functional Gastrointestinal
Disorders. http://www.aboutibs.org/. Accessed June 19, 2015.
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SOURCE Synthetic Biologics, Inc.