ROCKVILLE, Md., May 11, 2017 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a late-stage clinical company
developing therapeutics that preserve the microbiome to protect and
restore the health of patients, today announced that the U.S. Food
and Drug Administration (FDA) has granted a Breakthrough Therapy
Designation for SYN-004 (ribaxamase) for the prevention of
Clostridium difficile infection. SYN-004 (ribaxamase) is the
Company's first-in-class oral enzyme designed to protect the gut
microbiome from disruption caused by certain intravenous (IV)
beta-lactam antibiotics.
The Breakthrough Therapy Designation is based on data from the
successful Phase 2b clinical trial of ribaxamase, which met its
primary endpoint of significantly reducing CDI. FDA Breakthrough
Therapy Designation is intended to expedite development and review
timelines when preliminary clinical evidence indicates that a drug
may demonstrate substantial improvement on one or more clinically
significant endpoints over available therapies for serious or life
threatening diseases. If approved by the FDA, SYN-004 (ribaxamase)
would be the first available drug designed to prevent
Clostridium difficile infection by protecting the gut
microbiome from antibiotic-mediated dysbiosis.
"We are delighted by the FDA's recognition of ribaxamase's
potential to prevent CDI, and the dire need to fill the current
void of an approved intervention," said Jeffrey Riley, President and Chief Executive
Officer. "Following this announcement, we have been asked and
anticipate requesting a Type-B multidisciplinary meeting with the
Agency for a comprehensive discussion on the overarching,
high-level drug development plan and pathway to licensure for
ribaxamase. We look forward to working closely with the FDA
throughout the development and review process and remain dedicated
to bringing this potentially paradigm-shifting approach to
antibiotic therapy to patients in critical need."
About Clostridium difficile
Infection
Clostridium difficile infection is the number one
hospital acquired infection in the U.S., with more than
453,0001 patients diagnosed annually. CDI results in
approximately 29,0001 deaths, $1.5 billion1 in additional healthcare
costs, as well as significant and sometimes prolonged illness.
About SYN-004 (ribaxamase) and the Phase 2b Study
SYN-004 (ribaxamase) is a first-in-class oral enzyme 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 CDI, pathogenic overgrowth and the emergence of
antimicrobial resistance (AMR). Synthetic Biologics initiated a
Phase 2b proof-of-concept clinical trial intended to evaluate the
effectiveness of ribaxamase to prevent the onset of primary C.
difficile infection (CDI), antibiotic-associated diarrhea (AAD)
and the emergence of antimicrobial resistance (AMR) in patients
hospitalized with a lower respiratory infection and receiving IV
ceftriaxone. Results from this trial indicate that patients
receiving ribaxamase achieved a 71.4% relative risk reduction
(p-value=0.045) in CDI rates compared to patients receiving
placebo. Analysis of the data also demonstrated a significant
reduction in new colonization by vancomycin-resistant enterococci
(VRE) for patients receiving ribaxamase compared to placebo
(p-value=0.0002). Adverse events reported during this trial were
comparable between treatment and placebo arms. Analysis of data
from several exploratory endpoints designed to evaluate
ribaxamase's ability to prevent the emergence and proliferation of
AMR in the gut microbiome is ongoing.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a late-stage
clinical company developing therapeutics that preserve the
microbiome to protect and restore the health of patients. The
Company's lead candidates poised for Phase 3 development are: (1)
SYN-004 (ribaxamase) which is designed to protect the gut
microbiome from the effects of certain commonly used intravenous
(IV) beta-lactam antibiotics for the prevention of C.
difficile infection, pathogenic overgrowth and the emergence of
antimicrobial resistance (AMR), 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 developing
preclinical stage monoclonal antibody therapies for the prevention
and treatment of pertussis and novel discovery stage
biotherapeutics for the treatment of phenylketonuria (PKU). For
more information, please visit Synthetic Biologics' website at
www.syntheticbiologics.com.
This release includes 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 the potential of ribaxamase to
prevent CDI, the anticipated request for a Type-B
multidisciplinary meeting with the Agency for a comprehensive
discussion on the overarching, high-level drug development plan and
pathway to licensure for ribaxamase, the intended expedited
development of ribaxamase due to Breakthrough Therapy
Designation, the potentially paradigm-shifting
approach to antibiotic therapy to patients in critical need,
and the ability of SYN-004 to protect the gut
microbiome from the disruption caused by certain intravenous
(IV) beta-lactam antibiotic and the industry data regarding the
expected incidence and economic burden of CDI. 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 that could cause
actual results to differ materially 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' product
candidates demonstrating safety and effectiveness, as well as
results that are consistent with prior results, Synthetic
Biologics' ability to initiate clinical trials and if initiated, to
complete them on time and achieve desired results and benefits,
Synthetic Biologics' clinical trials continuing enrollment as
expected, Synthetic Biologics' ability to obtain regulatory
approvals for commercialization of product candidates or to comply
with ongoing regulatory requirements, regulatory limitations
relating to Synthetic Biologics' ability to promote or
commercialize its product candidates for specific indications,
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, Synthetic Biologics' ability to
maintain its license agreements, the continued maintenance and
growth of Synthetic Biologics' patent estate, Synthetic
Biologics becoming and remaining profitable, Synthetic
Biologics' ability to establish and maintain
collaborations, 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' Annual Report on Form 10-K for the year ended
December 31, 2016 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, excepted as required by law.
1: Leffler DA et al. N Engl J Med 2015; 372:
1539-1548
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SOURCE Synthetic Biologics, Inc.