ROCKVILLE, Md., Dec. 8, 2015 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a clinical stage company focused
on developing therapeutics to protect the gut microbiome, announced
positive topline results from the four week Phase 2 clinical trial
of SYN-010 for the treatment of irritable bowel syndrome with
constipation (IBS-C).
"We are pleased to report that SYN-010, a proprietary
modified-release formulation of lovastatin lactone, lowered breath
methane and improved stool frequency in patients with IBS-C,"
stated Joseph Sliman, M.D., MPH,
Senior Vice President, Clinical & Regulatory Affairs of
Synthetic Biologics.
"Methane is believed to be a causative factor in constipation,
and the primary objective of this trial was to ascertain whether
SYN-010 could lower breath methane either at the 7 or 28 day level.
The results show that high dose SYN-010 (42 mg) lowered methane at
the 7-day and 28-day time point, and low dose SYN-010 (21 mg)
lowered methane after 28 days. The inserted graph, which is
modified from the scientific abstract we submitted to Digestive
Disease Week 2016, depicts methane decreases within dose groups
before and after 7 or 28 days of treatment."
Dr. Sliman continued, "We were pleasantly surprised that, in
addition to methane reduction, we saw improvements in clinical
outcomes despite the small size of this study. We saw improvements
in stool frequency response for the 21 mg dose group and in weekly
abdominal pain intensity for the 42 mg dose group, both outcome
measures are patterned after the FDA IBS guidance."
"The completion of this four week exploratory Phase 2 clinical
trial for SYN-010 is an important milestone for Synthetic
Biologics. Positive clinical outcomes in this study are encouraging
and bring us closer to offering relief to the millions of people
who suffer from the symptoms of IBS-C, while at the same time
preserving the important balance of their microbiome," stated
Jeffrey Riley, Chief Executive
Officer.
Mr. Riley concluded, "The second Phase 2 clinical trial for
SYN-010 is currently underway and is evaluating the higher dose of
SYN-010 (42 mg) during an additional eight week period in patients
who rolled over from the first study. We expect to report topline
results from the second Phase 2 trial during the first quarter of
2016 and planning of the Phase 3 trial is underway. We are hosting
a Microbiome Clinical Program Seminar in NYC on Thursday, December 10, 2015 where we will present
the detailed results of this first Phase 2 trial, along with others
relevant to our clinical development programs."
About the First SYN-010 Phase 2 Clinical Trial
SYN-010 is Synthetic Biologics' 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. SYN-010 is
intended to act primarily in the intestinal lumen, ideally limiting
systemic absorption, thereby targeting a major cause of IBS-C, not
just the symptoms.
In this four week Phase 2 study, 63 patients with IBS-C and a
breath methane value > 10 parts per million at screening were
randomly assigned to receive placebo, a 21 mg SYN-010 dose or a 42
mg SYN-010 dose orally once daily for 28 days. The primary endpoint
was the change from baseline in the area under the curve (AUC) of
breath methane production at day 7, based on a 180-minute lactulose
breath test (LBT). Secondary efficacy assessments included change
in methane AUC at day 28, stool frequency and consistency,
abdominal pain, and safety data. A necessary normalization of the
severely left-skewed breath test data, not prespecified in the
statistical analysis plan, was accomplished by square root
transformation; paired t-tests were performed allowing each subject
to serve as their own control. The analyses of the clinical
outcomes were performed with untransformed raw data. While this
study was considered exploratory in nature and no formal hypothesis
testing was prespecified, p-values of less than 0.10 are generally
considered 'significant' in Phase 2 proof-of-concept studies.
SYN-010 effects on breath methane were evaluated in a within
group analysis by comparing the methane area under the curve (AUC)
on a lactulose breath test at Day 7 vs. baseline Day 1 or Day 28
vs. baseline Day 1. After 7 days reductions in breath methane
levels were seen in the 42 mg dose group (p=0.02) but not the 21 mg
dose group (p=0.64). In contrast, after 28 days both the 21 mg
(p=0.03) and 42 mg (p=0.01) dose groups showed reductions in breath
methane levels.
Preliminary analysis of secondary efficacy assessment data
indicates that an improvement in the stool frequency response for
the 21 mg dose group (p=0.02) was apparent, while the 42 mg dose
group (p=0.54) was numerically better demonstrating a positive
trend. Additionally, an improvement in weekly abdominal pain
intensity for the 42 mg dose group (p=0.08) was seen, while the 21
mg dose group (p=0.26) was numerically better demonstrating a
positive trend. The definitions of these outcomes are consistent
with the U.S. Food and Drug Administration (FDA) IBS guidance.
There were no serious adverse events observed.
Synthetic Biologics' 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' Microbiome Clinical Program
Seminar Webcast
Synthetic Biologics is hosting its Microbiome Clinical Program
Seminar on Thursday, December 10,
2015 in New York City at
9:00 a.m. EST. The Seminar will
provide clinical updates on Synthetic Biologics' gut microbiome
candidates – SYN-010 (treatment of IBS-C) and SYN-004 (prevention
of C. difficile). A live webcast of the presentations will
begin on December 10, 2015 at
9:00 a.m. EST and are scheduled to
conclude by 11:30 a.m. EST. The live
webcast of the event will be available via the internet at:
http://bit.ly/1QWBpYN. The archived webcast will be available at
the same URL, http://bit.ly/1QWBpYN, for at least 90 days following
the Seminar.
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 ability of SYN-010
to reduce methane production for the treatment of IBS-C while
minimizing disruption to the microbiome, SYN-010's ability to act
primarily in the intestinal lumen, the anticipated timing of the
reporting of topline data from the second Phase 2 eight week
extension study, timing of initiation of SYN-010 Phase 3 clinical
trial, the belief that methane is a causative factor in
constipation, 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 or results that are
consistent to prior trial results, 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.
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SOURCE Synthetic Biologics, Inc.