ROCKVILLE, Md., Sept. 20, 2016 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a clinical stage company focused
on developing therapeutics to protect the gut microbiome while
targeting pathogen-specific diseases, announced today that
following the completion of a previously planned interim analysis
by an independent Interim Analysis Committee (IAC), enrollment has
been completed in its Phase 2b randomized, placebo-controlled,
proof-of-concept clinical trial for SYN-004 (ribaxamase).
Following a closed session with the IAC in which the Company
remained blinded to the study data, a recommendation was given to
continue the study per protocol without modification and no safety
issues were identified. Successful enrollment of 413 patients has
occurred exceeding the desired sample size of 372 patients outlined
per the study protocol. All ongoing patients are expected to
continue through the follow-up period in order to complete the
study. The Company anticipates announcing top-line results during
the first quarter of 2017.
"The completion of enrollment in our Phase 2b proof-of-concept
study for ribaxamase represents a critical milestone for the
company and one that exhibits our continued focus of moving our
innovative approach to preventing CDI, AAD and antibiotic
resistance into late-stage clinical development," said Jeffrey Riley, President and Chief Executive
Officer. "We would like to thank the patients and clinical sites
that are participating in this study as well as our colleagues for
their commitment and dedication to this important and potentially
groundbreaking clinical trial. We look forward to announcing
top-line results during the first quarter of 2017."
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, AAD and the emergence of antibiotic-resistant
organisms. The Phase 2b proof-of-concept clinical trial is intended
to evaluate the effectiveness of ribaxamase to prevent the onset of
C. difficile infection (CDI), C. difficile associated
diarrhea (CDAD), antibiotic-associated diarrhea (AAD) and the
emergence of antibiotic-resistant organisms in patients
hospitalized with a lower respiratory infection and receiving
intravenous (IV) ceftriaxone. To access the ribaxamase mechanism of
action video on Synthetic Biologics' website, please click
here.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical stage
company developing therapeutics to protect the gut microbiome while
targeting pathogen-specific diseases. The Company's lead candidates
poised for Phase 3 development are: (1) 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), and (2) 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, antibiotic-associated
diarrhea (AAD) and the emergence of antibiotic-resistant organisms.
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 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 the expectation that all
ongoing patients will continue through the follow-up period in
order to complete the study, the anticipated announcement of
top-line results during the first quarter of 2017,
Synthetic Biologics' continued focus of moving its innovative
approach to preventing CDI, AAD and antibiotic resistance into
late-stage clinical development, the intended evaluation in
the Phase 2b proof-of-concept clinical trial of the effectiveness
of ribaxamase to prevent the onset of C. difficile infection (CDI),
C. difficile associated diarrhea (CDAD) and antibiotic-associated
diarrhea (AAD) in patients hospitalized with a lower respiratory
infection and receiving intravenous (IV) ceftriaxone, the
potentially groundbreaking nature of this trial and the intended
results to be achieved by use of SYN-010 and
SYN-004. 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
and 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'
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 ability to successfully design a
protocol and a corresponding statistical analysis plan to support
the execution of the first pivotal clinical trial for SYN-010,
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,
2015 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.