ROCKVILLE, Md., July 30, 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
has received a study-may-proceed letter from the U.S. Food and Drug
Administration (FDA) for the first clinical study of SYN-020, an
oral formulation of recombinant intestinal alkaline
phosphatase.
Synthetic Biologics intends to conduct a Phase 1 single
ascending dose study in healthy volunteers, designed to evaluate
SYN-020 for safety, tolerability, and pharmacokinetic parameters,
during the first quarter of 2021. The Phase 1 clinical program is
intended to support the clinical development of SYN-020 in multiple
indications, including for the treatment of radiation enteropathy
secondary to pelvic cancer therapy.
"Receipt of the study-may-proceed letter from the FDA is a
significant milestone for our SYN-020 program, which we believe
will demonstrate an important role in regulating and maintaining GI
and microbiome health," said Steven A.
Shallcross, Chief Executive and Financial Officer. "We are
excited to begin a clinical development program with an initial
indication intended to evaluate SYN-020's ability to mitigate the
intestinal damage caused by radiation therapy routinely used to
treat pelvic cancers. Looking ahead, we will continue to explore
additional indications where the use of orally administered IAP may
have a profound impact on treating and preventing age-related
metabolic and inflammatory diseases."
Synthetic Biologics previously announced an agreement with
Massachusetts General Hospital (MGH) granting the Company an option
for an exclusive worldwide license to intellectual property and
technology related to the use of 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.
About SYN-020 Intestinal Alkaline Phosphatase (IAP)
SYN-020 is a purified recombinant bovine IAP formulated for oral
delivery to the intestines. 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 been able 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 patients with pelvic cancers.
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 conducting a Phase 1 single ascending
dose study in healthy volunteers, designed to evaluate SYN-020 for
safety, tolerability, and pharmacokinetic
parameters, SYN-020 demonstrating an important
role in regulating and maintaining gastrointestinal and microbiome
health, SYN-020's potential to mitigate the
intestinal damage caused by radiation therapy routinely used to
treat pelvic cancers, the use of orally administered IAP having a
profound impact on treating and preventing age-related metabolic
and inflammatory diseases and plans to use the
license in the advancement of an expanded clinical development
program for 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, ability to obtain FDA clearance of the IND
for the SYN-020 program, a failure of additional pre-clinical
studies of SYN-020 to achieve similar results to those previously
achieved or to provide support for exercise of the option, the
ability to enter into a license to advance an expanded clinical
development program for SYN-020, 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.