ROCKVILLE, Md., June 29, 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 patient dosing and observation has
been completed in its Phase 1, open label, single-ascending dose
(SAD) clinical trial of SYN-020 intestinal alkaline phosphatase
(IAP). The Phase 1 SAD study enrolled 24 healthy adult volunteers
into four cohorts with SYN-020 given orally as single doses ranging
from 5 mg to 150 mg daily. 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 the study drug. No serious adverse events were
reported.
A second Phase 1 clinical trial intended to evaluate the safety,
tolerability and biodistribution of multiple-ascending doses (MAD)
of SYN-020 in healthy volunteers is expected to commence during the
third quarter of 2021. Topline results from this clinical trial are
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,
nonalcoholic fatty liver disease (NAFLD), radiation enteropathy,
and indications to treat and prevent metabolic and inflammatory
disorders associated with aging, which are supported by the
Company's collaboration with Massachusetts General Hospital.
"SYN-020 is a promising, versatile program that has the
potential to become a multi-indication, platform therapeutic
capable of addressing a considerable unmet need for innovative new
therapies targeting disorders stemming from gastrointestinal (GI)
inflammation, including celiac disease, NAFLD, and age-related
metabolic and inflammatory diseases," said Steven A. Shallcross, Chief Executive Officer of
Synthetic Biologics. "U.S. cases of celiac disease are expected to
surpass 4.3 million by 2023, representing a significant market
opportunity for a highly differentiated product such as SYN-020. We
are very encouraged by these positive Phase 1 results and look
forward to SYN-020's continued development, which includes the
planned initiation of a second Phase 1, multiple-ascending dose
study during the third quarter of 2021."
SYN-020 is a recombinant bovine IAP formulated for oral delivery
to the small intestine and designed 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.
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 commencing a second
Phase 1 clinical trial intended to evaluate the safety,
tolerability and biodistribution of multiple-ascending doses (MAD)
of SYN-020 in healthy volunteers during the third quarter of 2021,
announcing topline results from the second Phase 1 clinical trial
during the second quarter of 2022, the Phase 1 SAD and MAD
studies supporting the development of SYN-020 in multiple potential
clinical indications, including celiac disease, nonalcoholic fatty
liver disease (NAFLD), radiation enteropathy, and indications to
treat and prevent metabolic and inflammatory disorders associated
with aging, SYN-020 having the potential to become a
multi-indication, platform therapeutic capable of addressing a
considerable unmet need for innovative new therapies targeting
disorders stemming from gastrointestinal (GI) inflammation,
including celiac disease, NAFLD, and age-related metabolic and
inflammatory diseases, the expected increase in the number
of cases of celiac disease in the U.S 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-020 in multiple indications, the ability to
commence a multiple-ascending dose study of SYN-020 during
the third quarter of 2021 and the announcement of topline data
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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/synthetic-biologics-provides-update-on-syn-020-intestinal-alkaline-phosphatase-phase-1-single-ascending-dose-clinical-trial-301321668.html
SOURCE Synthetic Biologics, Inc.