ROCKVILLE, Md., Feb. 17, 2016 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a clinical stage company focused
on developing therapeutics to protect the gut microbiome, announced
today that the U.S. Patent and Trademark Office (USPTO) issued a
Notice of Allowance for a patent application which covers the use
of a variety of compounds, including the active agent of SYN-010,
the Company's proprietary, modified-release formulation of
lovastatin lactone designed to treat a major underlying cause of
irritable bowel syndrome with constipation (IBS-C).
U.S. Patent Application No. 14/211,197 also includes claims that
provide protection for proprietary patient screening technology
developed by Mark Pimentel, M.D.,
FRCP(C), Director of Cedars-Sinai Medical Center (CSMC)'s GI
Motility Program and Laboratory and Chairman of Synthetic
Biologics' IBS-C Clinical Advisory Board. Upon issuance, this
patent, which is owned by CSMC and exclusively licensed to
Synthetic Biologics, strengthens the Company's extensive
SYN-010-related patent estate and extends the term of the Company's
patent protection to at least 2034.
In November 2015, the USPTO issued
the first U.S. patent directly pertaining to the use of SYN-010.
The issuance of this new patent, which is also owned by CSMC and
exclusively licensed to Synthetic Biologics, expands the SYN-010
intellectual property portfolio to approximately 55 issued U.S. and
foreign patents. In addition, there are approximately 15 U.S. and
foreign patents pending, which upon issuance will further
strengthen the intellectual property position surrounding
SYN-010.
"The allowance of this patent in conjunction with our recent
announcement of positive topline data from the Phase 2 clinical
trials of SYN-010, demonstrates the progress we have made toward
our goal of bringing this important therapy to IBS-C patients,"
said Jeffrey Riley, President and
Chief Executive Officer of Synthetic Biologics. "As we plan for an
end of Phase 2 meeting with the FDA and to initiate Phase 3
clinical trials during 2016, we look forward to building long-term
value for our shareholders."
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. Methane produced by M. smithii is perceived
as an underlying cause of bloating, pain and constipation
associated with 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, 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
collaboration with Intrexon Corporation (NYSE: XON), the Company is
developing preclinical stage monoclonal antibody therapies 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 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 progress made toward the goal of bringing
SYN-010 to IBS-C patients, plans for an end of Phase 2
meeting with the FDA to initiate Phase 3 clinical trials during
2016, building long term value for shareholders, SYN-004
protecting the gut microbiome from the effects of commonly used IV
antibiotics for the prevention of C. difficile infection and
SYN-010 reducing the impact of methane producing organisms in the
gut microbiome to treat the underlying cause of IBS-C and AAD.
These forward-looking statements are based 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, 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 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 and other factors described in Synthetic
Biologics' report on Form 10-K for the year ended December 31, 2014 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.