ROCKVILLE, Md., Jan. 3, 2019 /PRNewswire/
-- Synthetic Biologics, Inc. (NYSE American: SYN),
a late-stage clinical company developing therapeutics designed to
preserve the microbiome to protect and restore the health of
patients, today announced that the first two patients have been
enrolled in SYN-010's Phase 2b
investigator-sponsored clinical study. SYN-010 is a proprietary,
modified-release reformulation of lovastatin lactone designed to
reduce methane production by certain microorganisms (M.
smithii) in the gut to treat an underlying cause of irritable
bowel syndrome with constipation (IBS-C). Cedars-Sinai Medical
Center (CSMC) and Synthetic Biologics are co-funding the study,
which will further assess the efficacy and safety of SYN-010 in
patients diagnosed with IBS-C.
"IBS with constipation can be debilitating for millions of
people worldwide, and this study will go a long way toward helping
identify whether SYN-010 can become a valuable tool in addressing
the underlying causes and offering relief to those patients," said
Mark Pimentel, M.D., head of the
Pimentel Laboratory and executive director of the Medically
Associated Science and Technology (MAST) Program at CSMC.
The Phase 2b study is being conducted by the MAST Program at CSMC
and comprises a 12-week, placebo-controlled, double-blind,
randomized clinical trial to evaluate two dose strengths of oral
SYN-010 (21 mg and 42 mg) in approximately 150 patients diagnosed
with IBS-C. A data readout from this investigator-sponsored
clinical study is expected during the second half of 2019.
"We are very excited to begin enrollment of our SYN-010 Phase
2b investigator-sponsored clinical
study," said Steven A. Shallcross,
Chief Executive Officer of Synthetic Biologics. "SYN-010 remains an
integral component in our portfolio of microbiome-focused assets
and represents a promising and differentiated approach to treating
the underlying cause of the symptoms commonly associated with
IBS-C. This study will be instrumental in our efforts to expand and
fortify the already well-established dataset for SYN-010 and may
help determine the optimal dose strength of SYN-010 for potential
future registration studies."
The primary objective for the study will be to determine the
efficacy of SYN-010, measured as an improvement from baseline in
the weekly average number of complete spontaneous bowel movements
(CSBMs) during the 12-week treatment period for SYN-010 21 mg and
42 mg daily doses relative to placebo. Secondary efficacy endpoints
for both dose strengths of SYN-010 are expected to measure changes
from baseline in abdominal pain, bloating, stool frequency as well
as the use of rescue medication relative to placebo. Exploratory
outcomes include Adequate Relief and quality of life measures using
the well-validated EQ-5D-5L and PAC-SYM patient questionnaires.
The patent rights covering the use of SYN-010 are owned by
Cedars-Sinai Medical Center and are exclusively licensed by
Cedars-Sinai Medical Center to Synthetic Biologics. Both
Cedars-Sinai and Dr. Pimentel have a financial interest in
Synthetic Biologics.
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 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 learn more about SYN-010's unique mechanism of action,
please click here.
About Cedars-Sinai Medical Center
Cedars-Sinai is a national leader in providing high-quality,
patient-centered healthcare encompassing primary care as well as
specialized medicine and conducting research that leads to
lifesaving discoveries and innovations. Since its beginning in
1902, Cedars-Sinai has evolved to meet the healthcare needs of one
of the most diverse regions in the nation, continually setting new
standards in quality and innovation in patient care, research,
teaching and community service.
Today, Cedars-Sinai is widely known for its national leadership
in transforming healthcare for the benefit of patients.
Cedars-Sinai impacts the future of healthcare globally by
developing new approaches to treatment and educating tomorrow's
physicians and other health professionals. At the same time,
Cedars-Sinai demonstrates a longstanding commitment to
strengthening the Los Angeles
community through wide-ranging programs that improve the health of
its most vulnerable residents.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American: SYN) is a late-stage
clinical company developing therapeutics that preserve the
microbiome to protect and restore the health of patients. The
Company's lead late-stage candidates are: (1) SYN-004 (ribaxamase)
which is designed to protect the gut microbiome from the effects of
certain commonly used intravenous (IV) beta-lactam antibiotics to
prevent microbiome damage, C.
difficile infection (CDI), overgrowth of pathogenic
organisms and the emergence of antimicrobial resistance (AMR), 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). The
Company's preclinical pursuits include an oral formulation of the
enzyme intestinal alkaline phosphatase (IAP) to treat both local GI
and systemic diseases as well as monoclonal antibody therapies for
the prevention and treatment of pertussis. For more
information, please visit Synthetic Biologics' website at
www.syntheticbiologics.com.
This release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. 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, and includes statements
regarding SYN-010 representing a promising and
differentiated approach to treating the underlying cause of the
symptoms commonly associated with IBS-C, potential future
registration studies, the planned design of the Phase
2b study, the expected
data readout from this investigator-sponsored clinical study during
the second half of 2019, the potential of SYN-010 to treat
the cause of IBS-C not just the symptoms and, the study helping to
determine the optimal dose strength of SYN-010 for potential future
registration studies. These forward-looking statements are
based on management's expectations and assumptions as of the date
of this press release and are subject to a number of risks and
uncertainties, many of which are difficult to predict that could
cause actual results to differ materially from current expectations
and assumptions from those set forth or implied by any
forward-looking statements. Important factors that could cause
actual results to differ materially from current expectations
include, among others, the ability to receive Institutional Board
Approval of the Phase 2b trial
protocol, the ability to commence the trial when anticipated, the
results of the SYN-010 trial demonstrating support for the use of
SYN-010 to treat symptoms of IBS-C, Synthetic Biologics' ability to
regain compliance with the continued listing standards of the NYSE
American by September 2, 2019,
Synthetic Biologics' ability to comply with other continued listing
requirements of the NYSE American, the ability of its product
candidates to demonstrate safety and effectiveness, as well as
results that are consistent with prior results, Synthetic
Biologics' clinical trials continuing enrollment as expected, a
failure to receive the necessary regulatory approvals for
commercialization of Synthetic Biologics' therapeutics, including
approval of proposed trial designs, a failure of Synthetic
Biologics' clinical trials, and those conducted by investigators,
for SYN-004 and SYN-010 to be commenced or completed on time or to
achieve desired results and benefits, a failure of Synthetic
Biologics' clinical trials to continue enrollment as expected or
receive anticipated funding, a failure of Synthetic Biologics to
successfully develop, market or sell its products, Synthetic
Biologics' inability to maintain its material licensing agreements,
or a failure by Synthetic Biologics or its strategic partners to
successfully commercialize products, Synthetic Biologics' ability
to achieve acceptance of its product candidates in the marketplace
and the successful development, marketing or sale of Synthetic
Biologics' products by competitors that render Synthetic Biologics'
products obsolete or non-competitive, the continued maintenance and
growth of Synthetic Biologics' patent estate, Synthetic Biologics
becoming and remaining profitable, Synthetic Biologics' ability to
obtain or maintain the capital or grants necessary to fund its
research and development activities, a loss of any of Synthetic
Biologics' key scientists or management personnel and other factors
described in Synthetic Biologics' Form 10-K for the year ended
December 31, 2017 and its other
filings with the SEC, including subsequent periodic reports on
Forms 10-Q and 8-K. 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.