ROCKVILLE, Md., Jan. 19, 2016 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a clinical stage company focused
on developing therapeutics to protect the gut microbiome, reported
that the second Phase 2 clinical trial of its proprietary SYN-010
for the treatment of irritable bowel syndrome with constipation
(IBS-C) met its primary endpoint.
Topline data from all patients who completed the second Phase 2
clinical trial of SYN-010 showed a statistically significant
decrease in methane production (p=0.002) from the beginning of the
first Phase 2 study (Study 1 baseline - Day 1) to the end of the
second Phase 2 study (12 weeks of treatment - Day 84), thus meeting
the study's primary endpoint. There were no serious adverse events
observed.
Topline data from the second Phase 2 study also showed
improvements in secondary efficacy endpoints, including:
- A statistically significant reduction in the mean IBS Symptom
Severity Score (IBS-SSS; p<0.0001), which includes abdominal
pain, bloating, stool frequency and quality of life scores, for all
patients from Study 1 baseline to the end of the second Phase 2
study.
- An increase in the percentage of patients identified as Monthly
Responders, an FDA-defined composite measure incorporating
improvements in complete spontaneous bowel movements (CSBMs) and
abdominal pain.1
"These topline data demonstrate the positive effect of SYN-010
on decreasing gut methane production, abdominal pain and bloating,
and improving stool frequency and quality of life scores in IBS-C
patients who are breath-methane positive," said Dr. Pimentel,
Director of the GI Motility Program and Laboratory at Cedars-Sinai,
and Chairman of Synthetic Biologics' IBS-C Clinical Advisory Board.
"Current IBS-C treatments are focused on relieving symptoms. These
latest SYN-010 findings, along with previously reported topline
data, strongly suggest a potential role for SYN-010 in treating a
major underlying cause of IBS-C by reducing the production of
methane in the gut, versus relieving symptoms."
This second Phase 2, open-label SYN-010 clinical trial was
conducted for eight weeks at multiple centers in the United States. The primary endpoint of
this extension study was to evaluate the sustainability of the
effect of one daily dose strength (42 mg) of SYN-010 on breath
methane production in breath methane-positive patients with IBS-C.
Secondary endpoints included evaluation of the reduction in
abdominal pain and bloating, the improvement in stool frequency and
overall quality of life. Fifty-four patients, who completed the
first Phase 2 clinical trial of SYN-010 (a four-week study of
patients randomly assigned to receive placebo, a 21 mg SYN-010 dose
or a 42 mg SYN-010 dose once daily), rolled over into the second
Phase 2 clinical trial of SYN-010.
"Meeting the study endpoints and demonstrating positive clinical
outcomes in this Phase 2 trial of SYN-010 bring us closer to
offering a therapeutic to the millions of people who suffer from
IBS-C," said Jeffrey Riley, Chief
Executive Officer of Synthetic Biologics. "During the first half of
2016, we anticipate reporting detailed results from this Phase 2
clinical trial and requesting an end of Phase 2 meeting with the
FDA. Concurrent with the analysis of the Phase 2 data, we are
actively planning the Phase 3 program for SYN-010."
Conference Call
Synthetic Biologics' management will host a conference call
tomorrow, Wednesday, Jan. 20, 2016,
at 8:30 a.m. (ET), along with
featured guest speaker, Mark
Pimentel, MD, FRCP(C), Director of the GI Motility Program
and Laboratory at Cedars-Sinai, and Chairman of Synthetic
Biologics' IBS-C Clinical Advisory Board. The dial-in information
for the call is as follows: U.S. toll free: 1-888-347-5280 and
International: +1 412-902-4280.
Participants are asked to dial in 15 minutes before the start of
the call to register. The call will also be webcast over the
Internet at https://www.webcaster4.com/Webcast/Page/1096/12885. An
archive of the call will be available for approximately 90 days at
the same URL https://www.webcaster4.com/Webcast/Page/1096/12885
beginning approximately one hour after the call's conclusion.
About SYN-010
SYN-010 is a proprietary, modified-release formulation of
lovastatin lactone that is intended to reduce methane production by
certain microorganisms (M. smithii) in the gut while
minimizing disruption to the microbiome to treat an underlying
cause of IBS-C. SYN-010 is intended
to act primarily in the intestinal lumen while avoiding systemic
absorption, thereby targeting a 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.
About Synthetic Biologics' Breath Methane Publication in
Alimentary Pharmacology & Therapeutics
Synthetic Biologics' peer-reviewed article titled "Inhibition
of Methanogenic Archaea by Statins as a Targeted Management
Strategy for Constipation and Related Disorders", evaluating
the therapeutic potential and mechanism of action of certain
statins in inhibiting the production of methane was recently
published in the journal Alimentary Pharmacology &
Therapeutics. The article describes observational and experimental
studies which show a strong correlation between the production of
methane by the dominant methane-producing microorganism in the gut,
M. smithii, and slowed stool transit in the intestines
commonly seen in patients with IBS-C. To access the online
publication, please use the following link:
http://onlinelibrary.wiley.com/doi/10.1111/apt.13469/epdf.
About Irritable Bowel Syndrome
IBS affects an estimated 10 to 15 percent of the population, or
as many as 45 million people in North
America. 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 and current
FDA-approved therapies for the treatment of IBS-C, which include
prescription and over-the-counter laxatives, do little to treat the
underlying cause of the disease. These products provide patients
with temporary relief from the symptoms of constipation by
elevating the amount of water which passes through the
gastrointestinal tract, but tend to cause an IBS-C patient to swing
from suffering from constipation, to suffering from diarrhea.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical stage
company developing therapeutics to protect the microbiome while
targeting pathogen-specific diseases. The Company's lead candidates
in Phase 2 development include: (1) 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
(2) SYN-010 which is intended to reduce the impact of methane
producing organisms in the gut microbiome to treat an 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 preclinical stage monoclonal antibody
for the prevention and treatment of Pertussis and discovery stage
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 potential of
SYN-010 to reduce methane production for the treatment of
IBS-C, the ability of SYN-010 to protect the microbiome,
the size of the market, the anticipated timing of the
reporting of detailed results from the Phase 2 trial and an end of
Phase 2 meeting with the FDA, and initiating a Phase 3
clinical trial of 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.
1 A Monthly Responder is defined as a patient who has
a Weekly Response in at least 50% of the weeks of treatment during
the month. A Weekly Responder is defined as a patient who
experiences a decrease in weekly average score for worst abdominal
pain in the past 24 hours of at least 30% compared with Study 1
Baseline and a stool frequency increase of 1 or more CSBM per week
compared with Study 1 Baseline.
Logo - http://photos.prnewswire.com/prnh/20160105/319502LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/synthetic-biologics-reports-positive-topline-data-from-second-phase-2-clinical-trial-of-syn-010-in-patients-with-irritable-bowel-syndrome-with-constipation-ibs-c-300206500.html
SOURCE Synthetic Biologics, Inc.