ROCKVILLE, Md., June 12, 2015 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a clinical-stage company focused
on developing therapeutics to protect the microbiome while
targeting pathogen-specific diseases, dosed the first participant
in a second Phase 2a clinical trial of SYN-004. This trial will
evaluate the gastrointestinal (GI) antibiotic-degrading effects and
the safety of SYN-004, in the presence of the proton pump inhibitor
(PPI), esomeprazole. SYN-004 is the Company's candidate therapy
designed to degrade certain intravenous (IV) beta-lactam
antibiotics within the GI tract and maintain the natural balance of
the gut microbiome for the prevention of C. difficile
infection, antibiotic-associated diarrhea (AAD) and secondary
antibiotic-resistant infections.
C. difficile is the leading type of hospital acquired
infection and is frequently associated with IV antibiotic
treatment. Beta-lactam antibiotics are a mainstay in hospital
infection management, and include commonly used penicillin and
cephalosporin antibiotics, such as ceftriaxone. However,
antibiotics have the potential to cause unintended harmful effects
within the GI tract, including disruption of the natural balance of
the gut microbiome, leading to 1.1 million C. difficile
infections[i] and 30,000 C. difficile-related
deaths[ii] in the United
States each year.
PPIs are often used prophylactically in hospitalized patients.
Therefore, with guidance from the U.S. Food and Drug Administration
(FDA), Synthetic Biologics is conducting this study to demonstrate
the ability of SYN-004 to degrade an intravenous (IV) antibiotic in
the presence of a PPI.
"As participants complete the first Phase 2a clinical trial of
SYN-004, they have the option to continue the evaluation of SYN-004
by moving into this second Phase 2a clinical trial," stated
Joseph Sliman, M.D., M.P.H., Senior
Vice President, Clinical & Regulatory Affairs of Synthetic
Biologics. "Collecting data in this second Phase 2a trial allows us
to build a pharmacokinetics (PK) model, a valuable tool when
other antibiotics are evaluated in the future. We want to clearly
demonstrate the ability of SYN-004 to degrade antibiotics in the
gut, to protect the microbiome from the damaging effects of
antibiotics and dramatically reduce C. difficile infections
through prevention vs. treatment. We remain on track to complete
and report preliminary data from the first Phase 2a clinical trial
within the month, and to initiate the Phase 2b clinical trial in
the third quarter of this year."
This second Phase 2a multi-center, open-label, 2-period,
fixed-sequence study is expected to evaluate the ability of SYN-004
to degrade residual IV ceftriaxone in the GI tract in the presence
of a PPI in up to 20 healthy participants with functioning
ileostomies. The study consists of two treatment periods for all
participants: 1) the administration of SYN-004 and IV ceftriaxone,
and 2) the administration of SYN-004 and IV ceftriaxone in the
presence of esomeprazole, an approved, over-the-counter PPI. Chyme
samples will be collected from the participants to measure the
ability of SYN-004 to degrade the residual antibiotic. Participants
are expected to be enrolled at up to four trial sites located in
the United States and Canada.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical-stage
company focused on developing therapeutics to protect the
microbiome while targeting pathogen-specific diseases. The Company
is developing an oral biologic to protect the gut microbiome from
intravenous (IV) antibiotics for the prevention of C.
difficile infection (Phase 2a) and an oral statin treatment to
reduce the impact of methane producing organisms on irritable bowel
syndrome with constipation (IBS-C). In addition, the Company is
developing a monoclonal antibody combination for the treatment of
Pertussis in collaboration with Intrexon Corporation (NYSE: XON),
and a Phase 2 oral estriol drug for the treatment of
relapsing-remitting multiple sclerosis (MS) and cognitive
dysfunction in MS. 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 of
SYN-004 degrade certain IV beta-lactam antibiotics within
the GI tract and maintain the natural balance of the gut microbiome
for the prevention of C. difficile infection, the
anticipated timing of the reporting of preliminary data from the
Phase 2a clinical trial and the timing of initiation of the Phase
2b clinical trial and the potential market for SYN-004. 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] 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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[ii] U.S.
Department of Health & Human Services. Agency for Healthcare
Research and Quality. January 25, 2012.
http://www.ahrq.gov/news/nn/nn012512.htm Accessed: June 7.
2015.
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SOURCE Synthetic Biologics, Inc.