ROCKVILLE, Md., April 1, 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 six study participants were dosed in a
Phase 1a single-ascending dose clinical trial 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 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.
"We are excited about the initiation of this clinical study
which is an important milestone in furthering the clinical
development of SYN-020," said Steven A.
Shallcross, Chief Executive and Financial Officer. "We
believe SYN-020 has enormous potential to help address a
considerable unmet need for innovative new therapies targeting GI
disorders stemming from immune and inflammatory responses,
including celiac disease, non-alcoholic fatty liver disease, as
well as age-related metabolic and inflammatory diseases. In the
U.S. alone, prevalent cases of celiac disease are expected to
increase to 4.3 million by 2023, representing a significant market
opportunity for a highly differentiated product such as SYN-020. We
look forward to announcing topline results from this study as well
as commencing a multiple-ascending dose study of SYN-020
anticipated during the third quarter of 2021."
The Phase 1a study, which is now underway at Spaulding Clinical
Research, LLC of West Bend, WI, is
designed to evaluate safety, tolerability and pharmacokinetics of
four single-ascending doses of oral SYN-020 in healthy volunteers.
In all, up to 24 healthy adult volunteers will be enrolled into
four cohorts that will run sequentially, all of which will receive
oral SYN-020. During the third quarter of 2021, a topline data
readout is expected to be reported and a multiple-ascending dose
study of SYN-020 is planned to begin.
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 SYN-020 Phase 1 trial supporting development
of SYN-020 in multiple indications, SYN-202 having the
potential to help address a considerable unmet need for
innovative new therapies targeting GI disorders stemming from
immune and inflammatory responses, including celiac disease,
non-alcoholic fatty liver disease, as well
as age-related metabolic and inflammatory
diseases, the expected increase in the number of cases of celiac
disease in the U.S., announcing topline results from the SYN-020
study as well as commencing a multiple-ascending dose study of
SYN-020 during the third quarter of 2021 and the
intended benefits to be derived from SYN-004 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,
Synthetic Biologics' ability to develop SYN-010 in multiple
indications, the ability to announce topline
results from the SYN-020 study as well as commencing a
multiple-ascending dose study of SYN-020 during the third quarter
of 2021, 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.