ROCKVILLE, Md., June 27, 2017 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a late-stage clinical company
developing therapeutics that preserve the microbiome to protect and
restore the health of patients, 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 the active agent
of SYN-010, the Company's proprietary, modified-release formulation
of lovastatin lactone, for the treatment of constipation. Upon
issuance, this patent will strengthen the intellectual property
estate covering the use of SYN-010 for the treatment of IBS-C until
at least 2034, affording the Company an extended term for
commercialization.
U.S. Patent Application No. 14/776,465, which is owned by
Cedars-Sinai Medical Center (CSMC) and exclusively licensed to
Synthetic Biologics, is based on innovative research led by
Mark Pimentel, M.D., FRCP(C),
Program Director of CSMC's Medically Associated Science and
Technology (MAST) Program and Chairman of Synthetic Biologics'
IBS-C Clinical Advisory Board, which correlates methane production
in the gut by certain microorganisms (M. smithii) with
symptoms commonly associated with IBS-C.
The allowance of this new patent expands the SYN-010
intellectual property portfolio to approximately 55 issued U.S. and
foreign patents. In addition, there are approximately 25 U.S. and
foreign patents pending, which upon issuance should further
strengthen the intellectual property position surrounding
SYN-010.
"Once issued, this patent will extend the protection around the
use of SYN-010 to treat IBS-C by an additional eleven years and
significantly strengthens the opportunity to build long-term value
for our shareholders," said Jeffrey
Riley, President and Chief Executive Officer of Synthetic
Biologics. "We remain focused on the continued clinical advancement
of SYN-010 and are encouraged that we are making excellent progress
in providing patients with a novel, potentially best-in-class
therapy that directly targets an underlying cause of the symptoms
associated with IBS-C."
Previously announced results from Phase 2 clinical trials
conducted by Synthetic Biologics demonstrated SYN-010 significantly
reduced abdominal pain and bloating while also improving stool
frequency and quality of life scores without severe adverse events
in IBS-C patients. Following collaborative discussions with the
U.S. Food and Drug Administration (FDA), the Company announced the
approval of a Phase 2b/3 adaptive design pivotal trial intended to
further evaluate the efficacy and safety of 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 (M. smithii) in the gut while
minimizing disruption to the microbiome to treat an underlying
cause of IBS-C. Methane produced by M. smithii has been
correlated with 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 late-stage
clinical company developing therapeutics that preserve the
microbiome to protect and restore the health of patients. The
Company's lead candidates poised for Phase 3 development 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 for the prevention of C.
difficile infection, pathogenic overgrowth 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 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 includes 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 further strengthening of the patent portfolio and the
continued clinical advancement of SYN-010. 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 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 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' 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, 2016 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, excepted as required by law.
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SOURCE Synthetic Biologics, Inc.