ROCKVILLE, Md., March 1, 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
Notices of Allowance for three patent applications which cover
composition of matter claims and methods of protecting the gut
microbiome from certain beta-lactam antibiotics for the prevention
of C. difficile infection (CDI) and antibiotic-associated
diarrhea (AAD). These new allowances further strengthen the
Company's novel proprietary candidate, SYN-004, which is also
covered by a composition of matter patent in the U.S.
SYN-004 is designed to degrade certain intravenous (IV)
beta-lactam antibiotics excreted into the gastrointestinal (GI)
tract to maintain the natural balance of the gut microbiome. C.
difficile is associated with approximately 453,000 CDIs and
> 29,000 C. difficile-related deaths in the United States each year[i]. Upon issuance,
these newly allowed applications reinforce Synthetic Biologics'
extensive C. difficile-related patent estate, which includes
approximately 35 U.S. and foreign patents and approximately 30 U.S.
and foreign patent applications, and carry patent terms that extend
from at least 2031 to 2035.
"These new patents will complement our growing SYN-004 patent
estate and support our C. difficile prevention program,
including two ongoing Phase 2 clinical trials," said Jeffrey Riley, President and Chief Executive
Officer of Synthetic Biologics. "We're on schedule with respect to
patient enrollment in our global Phase 2b proof-of-concept clinical
trial intended to evaluate the ability of SYN-004 to prevent CDI
and AAD in patients hospitalized with a lower-respiratory tract
infection. During the first half of 2016, we also anticipate
announcing topline data from the second Phase 2a clinical trial
which is evaluating the ability of SYN-004 to degrade IV
ceftriaxone in the presence of a proton pump inhibitor."
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-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 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).
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 continued patient enrollment in the global
Phase 2b proof-of-concept clinical trial intended to evaluate the
ability of SYN-004 to prevent CDI and AAD in patients hospitalized
with a lower-respiratory tract infection, the anticipated
announcement of topline data during the first half of 2016 from the
second Phase 2a clinical trial which is evaluating the ability of
SYN-004 to degrade IV ceftriaxone in the presence of a proton pump
inhibitor and the intended benefit of SYN-010 and SYN-004.
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, 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.
[i] Leffler DA et al. N Engl J Med 2015;
372:1539-1548.
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SOURCE Synthetic Biologics, Inc.