ROCKVILLE, Md., Oct. 21, 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 that
enrollment has commenced and eight study participants were dosed in
the Company's Phase 1, placebo-controlled, multiple-ascending dose
(MAD) clinical study of SYN-020 intestinal alkaline phosphatase
(IAP).
SYN-020 is a recombinant bovine 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 manufacturing.
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 as an oral product.
"We are excited to announce the initiation of the Phase 1
multiple-ascending dose clinical study, which is an important
milestone in furthering the clinical development of SYN-020 for
multiple potential indications," said Steven A. Shallcross, Chief Executive Officer
and Chief Financial Officer. "SYN-020 is a promising, versatile
program that we believe has enormous potential to help address a
considerable need for innovative new therapies targeting disorders
that stem from immune and inflammatory damage to the intestine,
including celiac disease, non-alcoholic fatty liver disease
(NAFLD), age-related metabolic and inflammatory diseases, and
radiation enteropathy. We believe SYN-020 addresses a significant
unmet market need as the total prevalent cases of celiac disease
are expected to reach 4.3 million in 2023 in the U.S. alone. We
look forward to announcing topline results from this study during
the second quarter of 2022."
The ongoing Phase 1 placebo-controlled clinical study is
intended to evaluate the safety, tolerability and biodistribution
of SYN-020 upon repeated dosing in up to 32 healthy adult
volunteers. The study will be divided into four sequential cohorts
of eight participants, with SYN-020 (5 mg, 15, mg, 45 mg or 75 mg)
given orally twice daily for 14 days. A safety review will be
conducted at the end of each cohort to determine whether
progression to the next higher dose cohort is permissible. A
topline data readout from this clinical study is anticipated during
the second quarter of 2022, pandemic conditions permitting. A
previously completed Phase 1 single-ascending dose (SAD) clinical
study of SYN-020 enrolled 24 healthy adult volunteers into four
cohorts with SYN-020 given orally as a single dose ranging from 5
mg to 150 mg. Analyses of preliminary data demonstrated that
SYN-020 maintained a favorable safety profile, was well tolerated
at all dose levels, and no adverse events were attributed to study
drug. No serious adverse events were reported.
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 includes statements
regarding the clinical development of SYN-020 for
multiple potential indications; SYN-020 being a promising,
versatile program that has enormous potential to help address a
considerable need for innovative new therapies targeting disorders
that stem from immune and inflammatory damage to the intestine,
including celiac disease, non-alcoholic fatty liver disease
(NAFLD), age-related metabolic and inflammatory diseases, and
radiation enteropathy; SYN-020 addressing a significant unmet
market need and announcing topline results from the Phase 1,
placebo-controlled, multiple-ascending dose (MAD) clinical study of
SYN-020 intestinal alkaline phosphatase (IAP) 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, Synthetic Biologics' ability to develop
SYN-020 in multiple indications and address disorders that
stem from immune and inflammatory damage to the intestine,
the ability to announce topline results from the
SYN-020 study during the second quarter of 2022, the ability to
continue to comply with continued listing requirements of
the NYSE American, the ability of its product candidates to
demonstrate safety and effectiveness, as well as results that are
consistent with prior results, Synthetic Biologics' clinical trials
continuing and/or beginning enrollment as expected, a failure to
receive the necessary regulatory approvals for commencement of
clinical trials and 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-020 to be commenced
or completed on time or to achieve desired results and benefits, 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, 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 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.