ROCKVILLE, Md., Feb. 10, 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 topline safety
and tolerability results from a Phase 1b clinical trial of SYN-004,
the Company's investigational oral beta-lactamase enzyme designed
to protect the microbiome and prevent Clostridium difficile (C.
difficile) infection, antibiotic-associated diarrhea and
secondary antibiotic-resistant infections in patients receiving
intravenous (IV) beta-lactam antibiotic therapy.
The U.S. Centers for Disease Control and Prevention (CDC) has
identified C. difficile as an "urgent public health threat"
that often occurs in people who have had recent medical care with
IV antibiotics. These antibiotics can create a harmful imbalance in
the gut microbiome by killing "good" bacteria, giving C.
difficile a chance to multiply and cause diarrhea, which can
lead to dehydration, fever, abdominal pain, cramping, nausea,
colitis, and even death. In all, 24 million Americans receive IV
antibiotics annuallyi.
"This study further validates the potential of investigational
SYN-004 to become the first and only point-of-care therapy designed
to preserve the microbiome and prevent C. difficile
infection," said Jeffrey Riley,
Chief Executive Officer of Synthetic Biologics. "We plan to
initiate Phase 2 studies of SYN-004 in the first quarter of this
year to further evaluate our innovative prophylactic approach to
preventing C. difficile infection by protecting the gut
microbiome from the collateral damage caused by antibiotics. This
revolutionary approach potentially holds the hope of treating a
variety of GI, metabolic and CNS disorders."
The randomized, double-blind, placebo-controlled Phase 1b study
was designed to further evaluate the safety, tolerability and
pharmacokinetics of escalating doses of oral SYN-004 in healthy
adult volunteers. In all, the study enrolled 24 healthy adult
volunteers in three cohorts, with six participants in each cohort
receiving increasing doses of SYN-004 up to four times a day over a
seven-day period and two participants in each cohort receiving
placebo. No safety or tolerability issues were reported at dose
levels and dose regimens both meeting and exceeding those expected
post-licensure and registration. It is anticipated that topline
pharmacokinetics data from the SYN-004 Phase 1b clinical trial will
be reported during the first quarter of 2015.
SYN-004 is intended to block the unintended harmful effects of
antibiotics within the gastrointestinal (GI) tract, maintaining the
natural balance of the gut microbiome, potentially preventing the
1.1 million C. difficile infectionsii and 30,000
C. difficile-related deathsiii in the United States each year. Beta-lactam
antibiotics are a mainstay in hospital infection management and
include the commonly used penicillin and cephalosporin classes of
antibiotics. During 2012, 14.4 million U.S. patients received
approximately 117.6 million doses of IV beta-lactam
antibioticsiv that could be inactivated in the GI tract
by SYN-004.
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
constipation-predominant irritable bowel syndrome (C-IBS) and a
monoclonal antibody combination for the treatment of Pertussis
being developed in collaboration with Intrexon Corporation (NYSE:
XON). 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 anticipated
initiation of Phase 2 trials, the anticipated timing of the data
reports, the potential for SYN-004, 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, 2013 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 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.
iii 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.
iv 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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