ROCKVILLE, Md., August 3, 2021 /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
an amendment to the Company's option for an exclusive license with
Massachusetts General Hospital ("MGH") to include intellectual
property ("IP") and technology related to the use of SYN-020
intestinal alkaline phosphatase ("IAP"), the Company's proprietary
recombinant version of bovine IAP, to inhibit liver fibrosis in
select diseases, including nonalcoholic fatty liver disease
("NAFLD").
Synthetic Biologics previously announced an option agreement
with MGH to negotiate an exclusive license to IP and technology for
the use of SYN-020 to prevent and treat metabolic and inflammatory
diseases associated with aging. The option agreement has now been
expanded to include technology developed by MGH to use SYN-020 to
inhibit liver fibrosis in select diseases, including NAFLD. If
executed, the license agreement would further strengthen the
SYN-020 portfolio and build upon the Company's intention to pursue
SYN-020 for the treatment of NAFLD, and, in particular, to slow the
course of fibrosis associated with progressive disease.
"We are pleased to announce the expansion of our collaboration
with Massachusetts's General
Hospital and share their enthusiasm for SYN-020's potential to
address diseases associated with liver fibrosis such as
nonalcoholic fatty liver disease," said Steven A. Shallcross, Chief Executive Officer of
Synthetic Biologics. "We continue to view SYN-020 as a potential
platform therapeutic that has a remarkable opportunity to address a
considerable unmet need for innovative new therapies targeting GI
disorders stemming from immune and inflammatory responses."
Under the terms of the amended agreement, Synthetic Biologics is
granted an option to negotiate an exclusive worldwide license with
MGH to commercially develop SYN-020 to treat and prevent metabolic
and inflammatory diseases associated with aging and fibrosis of the
liver.
About SYN-020 Phase 1 SAD & MAD Clinical Trials
Synthetic Biologics recently announced the completion of patient
dosing and observation of its Phase 1 single-ascending dose ("SAD")
clinical trial of SYN-020 in 24 healthy adult volunteers. Results
from this trial demonstrated that SYN-020 maintained a favorable
safety profile, was well tolerated at all dose levels, and no
adverse events were attributed to SYN-020. No serious adverse
events were reported. A second Phase 1 multiple-ascending dose
("MAD") clinical trial of SYN-020 in healthy adult volunteers is
expected to commence during the third quarter of 2021 with topline
results anticipated during the second quarter of 2022. Both Phase 1
SAD and MAD studies are intended to support the development of
SYN-020 in multiple potential clinical indications, including
celiac disease, radiation enteropathy, metabolic and inflammatory
disorders associated with aging, and to inhibit fibrosis in select
diseases, including NAFLD.
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 in multiple potential
clinical indications, including celiac disease, nonalcoholic fatty
liver disease (NAFLD), radiation enteritis, and indications to
treat and prevent metabolic and inflammatory disorders associated
with aging.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American: SYN) is 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. 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 (a) microbiome damage, (b)
Clostridioides difficile infection (CDI), (c)
overgrowth of pathogenic organisms, (d) the emergence of
antimicrobial resistance (AMR), and (e) acute
graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell
transplant (HCT) recipients, and (2) SYN-020, a recombinant oral
formulation of the enzyme intestinal alkaline phosphatase (IAP)
produced under cGMP conditions and intended 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 SYN-020's potential to address diseases
associated with liver fibrosis such as nonalcoholic fatty liver
disease, SYN-020 addressing a considerable unmet need for
innovative new therapies targeting GI disorders stemming from
immune and inflammatory responses, and commencing a second Phase 1
multiple-ascending dose ("MAD") clinical trial of SYN-020 in
healthy adult volunteers during the third quarter of 2021 with
topline results anticipated during the second quarter of
2022. 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 to
successfully negotiate a license agreement with MGH, the ability of
preclinical and clinical studies to provide support of SYN-020
addressing diseases associated with liver fibrosis such
as nonalcoholic fatty liver disease and
targeting GI disorders stemming from immune and inflammatory
responses, 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-020 to be
commenced or completed on time, to provide topline data when
anticipated 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, 2020 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.