ROCKVILLE, Md., Aug. 2, 2016 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a clinical stage company focused
on developing therapeutics to protect the gut microbiome while
targeting pathogen-specific diseases, announced today the
completion of an End of Phase 2 meeting with the U.S. Food and Drug
Administration (FDA) for SYN-010, designed to treat an underlying
cause of the symptoms commonly associated with irritable bowel
syndrome with constipation (IBS-C).
Following a review of data from the two Phase 2 clinical trials
of SYN-010 conducted by Synthetic Biologics, a collaborative
discussion ensued with FDA to determine the optimal pathway to
advance SYN-010 into Phase 3 development. With the concepts of the
clinical program outlined, Synthetic Biologics was encouraged to
work closely with FDA on an adaptive trial design and corresponding
statistical analysis plan to support the execution of the first
pivotal clinical trial for SYN-010. Further dose exploration and
sensitivity analysis of breath methane levels for trial
participation are elements that will be addressed in the first
pivotal clinical trial for SYN-010.
"The completion of our End of Phase 2 meeting with FDA is an
exciting and decisive clinical milestone for Synthetic Biologics.
Outcomes from our two Phase 2 clinical trials continue to emphasize
the need for the development of a treatment that targets one of the
underlying causes of IBS-C and allows us to take the next step in
bringing a product to market with the potential to address this
largely unmet medical need." said Jeffrey
Riley, Chief Executive Officer. "We were very pleased with
the collaborative nature of our meeting with FDA as well as the
Agency's recommendations on the path forward towards a pivotal
trial for SYN-010."
About SYN-010
SYN-010 is a proprietary, modified-release formulation of
lovastatin lactone that is intended to reduce methane production by
certain microorganisms (Methanobrevibacter 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 tract while
minimizing systemic absorption of the cholesterol-lowering
metabolite form of lovastatin lactone, 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, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical stage
company developing therapeutics to protect the gut microbiome while
targeting pathogen-specific diseases. The Company's lead candidates
in Phase 2 development are: (1) 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), and (2) SYN-004 (ribaxamase) which is
designed to protect the gut microbiome from the effects of certain
commonly used intravenous (IV) beta-lactam antibiotics for the
prevention of C. difficile infection and
antibiotic-associated diarrhea (AAD). The Company is
also developing preclinical stage monoclonal antibody therapies for
the prevention and treatment of pertussis and novel discovery stage
biotherapeutics for the treatment of phenylketonuria (PKU). 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 include
statements regarding the timing of the interim analysis
and the potential benefits of ribaxamse and SYN-010,
including statements regarding working closely with FDA on an
adaptive trial design and corresponding statistical analysis plan
to support the execution of the first pivotal Phase 3 clinical
trial for SYN-010, the continued emphasis on the need for
development of a treatment that targets one of the underlying
causes of IBS-C and the taking of the next steps to bring
the product to market with the potential to address an unmet
medical need . 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, Synthetic Biologics'
product candidates demonstrating safety and effectiveness, as well
as results that are consistent with prior results, Synthetic
Biologics' ability to initiate clinical trials and if initiated, to
complete them on time and achieve desired results and benefits,
Synthetic Biologics ability to successfully design a
protocol and a corresponding statistical analysis plan to support
the execution of the first pivotal clinical trial for SYN-010,
Synthetic Biologics' clinical trials continuing enrollment as
expected, Synthetic Biologics' ability to obtain regulatory
approvals for commercialization of product candidates or to comply
with ongoing regulatory requirements, regulatory limitations
relating to Synthetic Biologics' ability to promote or
commercialize its product candidates for specific indications,
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, Synthetic Biologics'
ability to maintain its license agreements, the continued
maintenance and growth of Synthetic Biologics' patent
estate, Synthetic Biologics becoming and remaining profitable,
Synthetic Biologics' ability to establish and maintain
collaborations, 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' Annual Report on Form 10-K for the year ended
December 31, 2015 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.