ROCKVILLE, Md., Oct. 20, 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 experimental
results supporting the proposed therapeutic mode-of-action of
SYN-010 in irritable bowel syndrome with constipation (IBS-C) were
presented today in a poster at the American College of
Gastroenterology (ACG) Annual Meeting in Honolulu, HI. 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 Medical Center's (CSMC) GI
Motility Program and Laboratory, and Chairman of Synthetic
Biologics' IBS-C Clinical Advisory Board.
"The presentation at the ACG Annual Meeting highlighted the
therapeutic potential of SYN-010 for IBS-C," stated Jeffrey Riley, Chief Executive Officer for
Synthetic Biologics. "As we continue to move our IBS-C program
through two ongoing Phase 2 clinical trials, this research, along
with SYN-010's novel modified-release formulation of the widely
prescribed lovastatin lactone, provides a strong body of support
for SYN-010's efficacy in reducing methane levels in the gut. We
continue to expect topline results from the first Phase 2 clinical
trial of SYN-010 during the fourth quarter of 2015, and topline
results from the second Phase 2 clinical trial during the first
half of 2016."
Synthetic Biologics' proprietary SYN-010 is a modified-release
formulation of the lactone form of 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, and published reports have associated higher intestinal
methane production with increased constipation severity in IBS-C
patients. 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.
The CSMC poster, entitled "Lovastatin Lactone Inhibits Methane
Production in Human Stool Homogenates," included data from studies
comparing the effects of different statins and statin forms
(lactone vs. beta-hydroxyacid) on methane production by stool
homogenates from five female donors with high levels of breath
methane. Dr. Pimentel concluded that, of the various statins
examined, lovastatin lactone was the only effective inhibitor of
methane production in the stool homogenates, significantly
inhibiting methane levels by -65% compared to the control
stool.
"This lovastatin data suggests that SYN-010 has therapeutic
potential to diminish the production of methane in the gut, thereby
treating the cause of IBS-C, not just the symptoms," said Dr.
Mark Pimentel.
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
CSMC to Synthetic Biomics, Inc., a subsidiary of Synthetic
Biologics, Inc. CSMC also holds a minority equity interest in
Synthetic Biomics.
About Irritable Bowel Syndrome with Constipation
(IBS-C)
IBS is a functional gastrointestinal disorder that affects an
estimated 10 to 15 percent of the population, or as many as 45
million people in North
Americai. The illness affects both men and women;
however, two-thirds of diagnosed sufferers are women. Current U.S.
Food and Drug Administration (FDA)-approved therapies for the
treatment of IBS-C and other treatments including prescription and
over-the-counter laxatives, provide patients with temporary
symptomatic relief, but do not treat the underlying cause of pain,
bloating and constipation associated with IBS-C.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a
microbiome-focused, clinical-stage company developing therapeutics
to protect the microbiome while targeting pathogen-specific
diseases. The Company's lead candidates in Phase 2 development
include SYN-004 which is designed to protect the gut microbiome
from the effects of certain commonly used intravenous (IV)
antibiotics for the prevention of C. difficile infection and
antibiotic-associated diarrhea (AAD), and SYN-010 which is intended
to reduce the impact of methane producing organisms in the gut
microbiome to treat the underlying cause of irritable bowel
syndrome with constipation (IBS-C). In addition, the Company is
developing a Phase 2 oral estriol drug for the treatment of
relapsing-remitting multiple sclerosis (MS) and cognitive
dysfunction in MS, and in collaboration with Intrexon Corporation
(NYSE: XON), a monoclonal antibody combination for the treatment of
Pertussis and biotherapeutics for the treatment of phenylketonuria
(PKU). 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 therapeutic
potential for SYN-010, intended treatment for SYN-010, the
potential market for SYN 010, anticipated timing of the topline
results from the first and second Phase 2 trials, 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.
i The International Foundation for Functional
Gastrointestinal Disorders. http://www.aboutibs.org/.
Accessed June 19, 2015.
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