ROCKVILLE, Md., Jan. 7, 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 the receipt
of official meeting minutes from the U.S. Food and Drug
Administration (FDA) following a Type C meeting held on
December 2, 2019 at the Company's
request to discuss the development of SYN-004 (ribaxamase) in
allogeneic hematopoietic cell transplant (HCT) recipients who are
administered intravenous (IV) beta-lactam antibiotics in response
to fever.
"Our discussion with the FDA was extremely productive and
reinforces our optimism in the potential of SYN-004 (ribaxamase) to
prevent dysbiosis of the gut microbiome and significantly improve
outcomes for patients who undergo allogeneic HCT and are treated
with IV beta-lactam antibiotics," said Steven A. Shallcross, Chief Executive and
Financial Officer of Synthetic Biologics. "We remain focused on
working with the distinguished team at the Washington University School of Medicine in
St. Louis to finalize the clinical
program protocol in anticipation of the commencement of the Phase
1b/2a clinical study during the first
quarter of 2020."
Based on the final meeting minutes, the Phase 1b/2a study will comprise a single center,
randomized, double-blinded, placebo-controlled clinical trial of
oral SYN-004 (ribaxamase) in up to 36 evaluable adult allogeneic
HCT recipients. The goal of this study is to evaluate the safety,
tolerability and potential absorption into the systemic circulation
(if any) of 150 mg oral SYN-004 (ribaxamase) administered to
allogeneic HCT recipients who receive an IV beta-lactam antibiotic
to treat fever. Study participants will be enrolled into three
sequential cohorts administered a different study-assigned IV
beta-lactam antibiotic. Eight participants in each cohort will
receive SYN-004 (ribaxamase) and four will receive placebo.
Safety and pharmacokinetic data for each cohort will be reviewed
by an independent Data and Safety Monitoring Committee, which will
make a recommendation on whether to proceed to the next IV
beta-lactam antibiotic. The study will also evaluate potential
protective effects of SYN-004 (ribaxamase) on the gut microbiome as
well as generate preliminary information on potential therapeutic
benefits and patient outcomes of SYN-004 (ribaxamase) in allogeneic
HCT recipients. Enrollment is expected to begin during the first
quarter of 2020 contingent upon approval of the clinical study
protocol by the Washington University
School of Medicine's Institutional Review Board (IRB).
About SYN-004 (ribaxamase)
SYN-004 (ribaxamase) is an oral prophylactic therapy designed to
degrade certain IV beta-lactam antibiotics within the GI tract and
maintain the natural balance of the gut microbiome for the
prevention of Clostridioides 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.
Allogeneic HCT recipients routinely receive long courses of IV
beta-lactam antibiotics to treat infection. Antibiotic-mediated
damage of the gut microbiome in allogeneic HCT recipients has been
strongly associated with adverse outcomes including CDI,
vancomycin-resistant enterococci (VRE) colonization and potentially
fatal bacteremia and aGVHD. A previously completed
placebo-controlled Phase 2b clinical
trial of 412 patients demonstrated SYN-004 (ribaxamase) protected
the gut microbiome from antibiotic-mediated dysbiosis. Patients
receiving SYN-004 (ribaxamase) also demonstrated significantly
better maintenance and recovery of the gut microbiome as well as
lower incidences of new colonization by opportunistic and
potentially pathogenic microorganisms such as VRE.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE American: SYN) is a
clinical-stage company developing therapeutics that preserve the
microbiome to protect and restore the health of patients. 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 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, and has completed proof-of-concept
studies with monoclonal antibody therapies for the prevention and
treatment of pertussis. 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 potential protective effects of SYN-004
(ribaxamase) on the gut microbiome as well as generate preliminary
information on potential therapeutic benefits and patient outcomes
of SYN-004 (ribaxamase) in allogeneic HCT recipients,
enrollment expected to begin during the first quarter of
2020 contingent upon approval of the clinical study
protocol by the Washington University
School of Medicine's Institutional Review Board (IRB)
and the intended benefits to be derived from SYN-004, SYN-010
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 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-010 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 and 10-K/A for the year ended December
31, 2018 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.