ROCKVILLE, Md., Sept. 26, 2019 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE American: 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) has granted a U.S. patent and
issued a Notice of Allowance for a patent application covering
various aspects of the clinical SYN-010 program. These USPTO
issuances bolster the Company's patent portfolio supporting
SYN-010, the Company's proprietary, modified-release formulation of
lovastatin lactone, for the treatment of IBS-C. The current and
soon-to-be issued patents will also diversify and further
strengthen the IP estate covering the use of SYN-010 for the
treatment of IBS-C by providing composition of matter and patient
selection method of treatment claims and will provide the Company
exclusivity until at least 2035.
Recently granted U.S. Patent No. 10,328,151, which is co-owned
by Synthetic Biologics and Cedars-Sinai Medical Center (CSMC) and
exclusively licensed to Synthetic Biologics, covers the composition
of matter of the SYN-010 clinical agent. Recently allowed U.S.
Patent Application No. 15/810,891, which is owned by CSMC and
exclusively licensed to Synthetic Biologics, covers methods of
treating IBS-C with a statin, inclusive of SYN-010, in a selected
patient population.
"Our extensive patent estate, which includes approximately 60
granted patents and 25 pending applications worldwide, continues to
provide protection around our SYN-010 asset and is an important
component of our ongoing focus of building long-term value for our
shareholders," said Steven A.
Shallcross, Chief Executive Officer of Synthetic Biologics.
"Along with the continuing Phase 2b
investigator-sponsored clinical study of SYN-010 being conducted at
CSMC, these successes in the USPTO provide us with further momentum
in advancing SYN-010 as a much-needed treatment for the millions of
patients that continue to suffer from IBS-C."
About Irritable Bowel Syndrome
IBS affects an estimated 10 to 15 percent of
the U.S. 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 Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American: SYN) is a
clinical-stage company developing therapeutics that preserve the
microbiome to protect and restore the health of patients. The
Company's lead candidates are: (1) SYN-004 (ribaxamase) which is
designed to degrade certain commonly used intravenous (IV)
beta-lactam antibiotics within the gastrointestinal (GI) tract to
prevent microbiome damage, C. difficile infection (CDI),
overgrowth of pathogenic organisms, the emergence of antimicrobial
resistance (AMR) and acute graft-versus-host-disease (aGVHD) in
allogeneic hematopoietic cell transplant (HCT) recipients, 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 advancing SYN-020,
an early-stage oral formulation of the enzyme intestinal
alkaline phosphatase (IAP) designed to treat both local GI and
systemic diseases. 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 the strength of the patent estate and potential benefits
of SYN-004, SYN-010 and SYN-020. 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 of Synthetic Biologics' 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 to file INDs when anticipated, 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, Synthetic Biologics' ability
to continue to comply with other continued listing requirements of
the NYSE American, 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 and 10-K/A for the year ended
December 31, 2018 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.