ROCKVILLE, Md., May 27, 2020 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE American: SYN), a diversified
clinical-stage company leveraging the microbiome to develop
therapeutics designed to prevent and treat gastrointestinal ("GI")
diseases in areas of high unmet need, today announced that it
entered into an agreement with Massachusetts General Hospital
("MGH") granting the Company an option for an exclusive license to
intellectual property and technology related to the use of
intestinal alkaline phosphatase ("IAP") to maintain GI and
microbiome health, diminish systemic inflammation, and treat
age-related diseases. If executed, the Company plans to use this
license in the advancement of an expanded clinical development
program for SYN-020, the Company's proprietary recombinant version
of bovine IAP currently in pre-clinical development.
The promise of MGH's IAP research was described earlier this
year in the peer-reviewed journal JCI Insight. A team of
investigators led by Richard Hodin,
MD, Chief of the Massachusetts General Hospital Division of General
and Gastrointestinal Surgery and Professor of Surgery, Harvard Medical School, evaluated long-term oral
supplementation of IAP, including SYN-020, in mice. IAP
administration, starting at 10 months of age, slowed the microbiome
changes, gut-barrier dysfunction, and gastrointestinal and systemic
inflammation that normally accompany aging. Additionally, the IAP
administration resulted in improved metabolic profiles in the aged
mice, diminished frailty, and extended lifespan.
Under the terms of the agreement, Synthetic Biologics is granted
exclusive rights to negotiate a worldwide license with MGH to
commercially develop SYN-020 to treat and prevent metabolic and
inflammatory diseases associated with aging.
"Multiple reported animal studies have demonstrated the high
therapeutic potential of IAP to promote GI and gut microbiome
health," said Steven A. Shallcross,
Chief Executive and Financial Officer of Synthetic Biologics. "We
are pleased to announce the expansion of our collaboration with
Massachusetts General Hospital on this exciting new therapeutic
approach and potential broader market opportunity for our SYN-020
IAP program. Dr. Hodin and his team's extensive research
complements our current focus and expertise, which includes the
development of clinical programs intended to treat and prevent
GI-related diseases."
Dr. Hodin noted that the gastrointestinal tract is increasingly
being recognized as a key factor in a variety of systemic diseases.
"Decades of research suggest that IAP plays a major role in
protecting us from the harmful effects of gut-derived mediators,"
he said. "I am very excited about the possibility of bringing IAP
from the research bench to the bedside in the hopes of benefiting
the health of many people."
About SYN-020 Intestinal Alkaline Phosphatase (IAP)
SYN-020 is a recombinant bovine Intestinal Alkaline Phosphatase
(IAP) formulated for oral delivery to the small intestine. The
published literature indicates that IAP functions to diminish
intestinal inflammation, tighten the gut barrier to diminish "leaky
gut," and promote a healthy microbiome. Despite its broad
therapeutic potential, a key hurdle to commercialization has been
the high cost of IAP manufacture. Synthetic Biologics has overcome
this hurdle and has the ability to produce SYN-020 at a scale and
cost viable for clinical and commercial development. Synthetic
Biologics is currently developing SYN-020 to reduce acute
intestinal side effects associated with radiation therapy in cancer
patients. The Company has completed the Investigational New Drug
("IND")-enabling studies required to support the filing of an IND
application for this program anticipated during the second quarter
of 2020.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American: SYN) is a
clinical-stage company leveraging the microbiome to develop
therapeutics designed to prevent and treat gastrointestinal (GI)
diseases in areas of high unmet need. The Company's lead clinical
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 oral formulation of the enzyme
intestinal alkaline phosphatase (IAP) 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 include statements
regarding plans to use the license in the
advancement of an expanded clinical development program for
SYN-020, the potential of IAP to promote GI and gut microbiome
health, diminish systemic inflammation, and treat
age-related diseases and the possibility of bringing
IAP from the research bench to the bedside in the hopes of
benefiting the health of many people and the filing of
an IND application for SYN-020 during the second quarter of
2020. 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 of additional pre-clinical studies
of SYN-020 to achieve similar results to those previously achieved
by Dr. Hodin or to provide support for exercise of the option, 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, for SYN-004 and SYN-010 to be commenced or completed
on time or to achieve desired results and benefits, especially in
light of COVID-19, 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 and other factors described in Synthetic
Biologics' Annual Report on Form 10-K for the year ended
December 31, 2019 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.