ROCKVILLE, Md., March 19, 2015 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a developer of pathogen-specific
therapies for serious infections and diseases, with a focus on
protecting the microbiome, today announced positive
pharmacokinetics (PK) results from both the Phase 1a and 1b studies
of SYN-004, which is being developed to protect the microbiome and
prevent Clostridium difficile (C. difficile) infection.
"The PK data confirmed that SYN-004 acts as Synthetic Biologics
intended. SYN-004 goes directly to the gut where intravenous (IV)
antibiotics are excreted, with the intention of protecting the
microbiome from a cascading set of events that often lead to
potentially deadly C. difficile infections," said
Jeffrey Riley, Chief Executive
Officer of Synthetic Biologics. "These data support our
expectations that SYN-004 should have no effect on the IV
antibiotic in the bloodstream, therefore allowing the antibiotic to
do its job and fight the primary infection. We look forward to
continuing the clinical evaluations of our lead candidate, SYN-004,
with the initiation of a Phase 2a clinical trial this month."
The Phase 1a, single-ascending dose PK study provided data to
support Synthetic Biologics' hypothesis that SYN-004 taken orally
was not systemically available in the dose range tested. The PK
data from this study measured blood levels of a single dose of
SYN-004 in participants over a 10-fold dose range. Minimal levels
of SYN-004 were observed in the bloodstream across the dose range
investigated in the participants.
The Phase 1b, multiple-ascending dose PK study provided data to
further support that SYN-004 is not systemically available, as no
meaningful levels of SYN-004 were observed in the bloodstream after
participants received multiple doses of SYN-004 four times a day
over a seven-day period. The PK data confirm Synthetic Biologics'
expectations based on previous data from the first generation
enzyme (P1A).
In addition, no clinically significant safety events were
observed, and both the single and multiple doses of SYN-004 were
well tolerated by the participants of the Phase 1 studies.
Synthetic Biologics intends to continue the clinical development of
SYN-004 in a Phase 2a clinical trial to evaluate the ability of
SYN-004 to degrade residual IV antibiotic in the gastrointestinal
(GI) tract, therefore potentially protecting the gut microbiome and
preventing C. difficile infection.
Currently, there is no vaccine or drug approved by the U.S. Food
and Drug Administration (FDA) specifically for the prevention of
C. difficile infection. The U.S. Centers for Disease Control
and Prevention (CDC) has identified C. difficile infection
as an "urgent public health threat" that occurs mostly in people
who have had recent medical care with IV antibiotics. SYN-004 is
intended to block the unintended harmful effects of antibiotics
within the GI tract and maintain the natural balance of the gut
microbiome, potentially preventing the 1.1 million C.
difficile infectionsi and 30,000 C.
difficile-related deathsii in the United States each year. Approximately 118
million doses of IV beta-lactam antibioticsiii that
could be inactivated in the GI tract by SYN-004, were administered
to approximately 14 million hospitalized U.S. patients during
2012.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical-stage
biotechnology company developing pathogen-specific therapies for
serious infections and diseases, with a focus on protecting the
microbiome. The Company is developing an oral biologic to protect
the gut microbiome from intravenous (IV) antibiotics for the
prevention of C. difficile infection, an oral statin
treatment to reduce the impact of methane producing organisms on
irritable bowel syndrome with constipation (IBS-C), and in
collaboration with Intrexon Corporation (NYSE: XON), a monoclonal
antibody combination for the treatment of Pertussis. 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. 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 intent to
continue the clinical development and evaluations of SYN-004 in a
Phase 2a study to evaluate the ability of SYN-004 to degrade
residual IV antibiotic in the gastrointestinal (GI) tract,
the intended benefits to be achieved from use of SYN-004,
including the potential prevention of C. difficile infections, 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.
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: September 30, 2013.
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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