ROCKVILLE, Md., Dec. 1, 2015 /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 positive topline results from the first Phase
2a study of SYN-004, the Company's candidate designed to protect
the gut microbiome from the unintended effects of certain commonly
used intravenous (IV) beta-lactam antibiotics for the prevention
C. difficile infection (CDI) and antibiotic-associated
diarrhea (AAD). Topline results from the ten ileostomized
participants who completed the Phase 2a open-label study
demonstrated that SYN-004 successfully degraded residual IV
ceftriaxone in the chyme (digestive fluid in the small intestine)
without affecting the intended level of ceftriaxone in the
bloodstream.
Evaluation of the chyme from the ileostomized participants
indicates that both dosage strengths of SYN-004 (75 mg and 150 mg)
degrade residual IV ceftriaxone present in the chyme, supporting
the mechanism of action of SYN-004. In addition, both dosage
strengths of SYN-004 appear to be well tolerated by the
participants in the study. Overall, the topline data support the
hypothesis that SYN-004 has the capacity to degrade residual IV
ceftriaxone in the GI tract, thereby preserving the balance of the
gut microbiome for the prevention of CDI, AAD and emergence of
antibiotic-resistant organisms, without affecting the antibiotic
level in the bloodstream intended for treatment of a primary
infection.
"The completion of the first Phase 2a clinical trial for SYN-004
is an important achievement for Synthetic Biologics. These positive
topline results demonstrate the potential for SYN-004 to protect
the gut microbiome from the damaging effects of certain IV
beta-lactam antibiotics for the prevention of C. difficile
infection and antibiotic-associated diarrhea," stated Jeffrey Riley, President and Chief Executive
Officer of Synthetic Biologics. "The second Phase 2a clinical trial
for SYN-004 is currently ongoing to evaluate the GI
antibiotic-degrading effects and the safety of SYN-004 in the
presence of the proton pump inhibitor (PPI), esomeprazole, in
participants with functioning ileostomies. We anticipate reporting
topline results from the second Phase 2a of SYN-004 during the
first half of 2016."
Mr. Riley concluded, "We are pleased to report additional
progress from our SYN-004 program. We have begun dosing patients in
the SYN-004 Phase 2b proof-of-concept clinical trial that is
intended to evaluate the effectiveness of SYN-004 to prevent C.
difficile infection and C. difficile associated
diarrhea, as well as antibiotic-associated diarrhea in up to 370
patients hospitalized for a lower respiratory tract infection and
receiving IV ceftriaxone."
About C. difficile
The U.S. Centers for Disease Control and Prevention (CDC) has
categorized C. difficile as an "urgent public health
threat," and has stated the need for research to better understand
the role of normal gut bacteria. SYN-004 is intended to block the
unintended harmful effects of certain IV beta-lactam antibiotics
within the GI tract and maintain the natural balance of the gut
microbiome, potentially preventing the 453,000 C. difficile
infectionsi and approximately 29,000 C.
difficile-related deathsii in the United States each year. During 2012,
approximately 14 million U.S. patients received approximately 118
million doses of IV beta-lactam antibioticsiii that
could be inactivated in the GI tract by SYN-004.
First SYN-004 Phase 2a Clinical Trial Design
The Phase 2a randomized, multi-center, open-label study
evaluated the ability of two different dose strengths of SYN-004 to
degrade residual IV ceftriaxone in the GI tract of 10 healthy
participants with functioning ileostomies, without affecting the
concentrations of IV ceftriaxone in the bloodstream. The study
consisted of two treatment phases for all participants: 1) the
administration of IV ceftriaxone alone, and 2) the administration
of IV ceftriaxone with one of two dosage strengths of oral SYN-004.
Chyme samples were collected from the participants to measure the
capability of SYN-004 to degrade the residual antibiotic in the GI
tract. Participants were enrolled at two trial sites located in
Canada.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical-stage
company developing therapeutics to protect the microbiome while
targeting pathogen-specific diseases. The Company's lead candidates
in Phase 2 development include: (1) SYN-004 which is designed to
protect the gut microbiome from the effects of certain commonly
used intravenous (IV) antibiotics for the prevention of C.
difficile infection and antibiotic-associated diarrhea (AAD), 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). In
addition, the Company is developing a Phase 2 oral estriol drug for
the treatment of relapsing-remitting multiple sclerosis (MS) and
cognitive dysfunction in MS, and in collaboration with Intrexon
Corporation (NYSE: XON), a preclinical stage monoclonal antibody
for the prevention and treatment of Pertussis and 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 on Synthetic
Biologics' current expectations and projections about future
events. 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. These statements are based
upon current beliefs, expectations and assumptions and are subject
to a number of risks and uncertainties, many of which are difficult
to predict and include statements regarding the potential
for SYN-004 to protect the gut microbiome from the damaging effects
of certain IV beta-lactam antibiotics for the prevention of C.
difficile infection and antibiotic-associated diarrhea, the timing
of the reporting of topline results from the second Phase 2a of
SYN-004, the potential market for SYN-004, and the intended
therapeutics results of SYN-004 and SYN-010. The
forward-looking statements are subject to 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
those reflected in Synthetic Biologics' forward-looking statements
include, among others, 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, to be commenced or completed
on time or to achieve desired results, a failure of Synthetic
Biologics' clinical trials to receive anticipated funding, a
failure of Synthetic Biologics' products for the prevention and
treatment of diseases to be successfully developed or
commercialized, Synthetic Biologics' inability to maintain its
licensing agreements, or a failure by Synthetic Biologics or its
strategic partners to successfully commercialize products and other
factors described in Synthetic Biologics' report on Form 10-K for
the year ended December 31, 2014 and
any other filings with the SEC. 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.
i Leffler DA et al. N Engl J Med 2015;
372:1539-1548.
ii Leffler DA et al. N Engl J Med 2015;
372:1539-1548.
iii This information is an estimate derived from the
use of information under license from the following IMS Health
Incorporated information service: CDM Hospital database for full
year 2012. IMS expressly reserves all rights, including rights of
copying, distribution and republication.
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SOURCE Synthetic Biologics, Inc.