ROCKVILLE, Md., Dec. 22, 2014 /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 1a clinical trial of SYN-004,
the Company's investigational oral beta-lactamase enzyme for the
prevention of Clostridium difficile (C. difficile)
infection, antibiotic-associated diarrhea and secondary
antibiotic-resistant infections in patients receiving intravenous
(IV) beta-lactam antibiotic therapy.
Since December 2nd, the
randomized double-blind, placebo-controlled Phase 1a clinical trial
conducted at Clinical Pharmacology of Miami, has enrolled 24 healthy volunteers in
three cohorts of eight patients each. A total of 18 volunteers have
been administered one dose of SYN-004 at increasing dose levels by
cohort, and six volunteers received placebo. No clinically
significant or relevant adverse events have been reported to
date.
"Completing the first safety review and reporting positive
topline results in the Phase 1a clinical trial of SYN-004 is an
important event for Synthetic Biologics, bringing us closer to the
first potential point-of-care preventative therapy for C.
difficile, the CDC's top-ranking public health threat.
Achieving this milestone moves us closer to validating our
ground-breaking approach to preventing C. difficile
infection in a way that protects the gut microbiome, which also
holds the hope of treating a variety of GI, metabolic and CNS
disorders," said Jeffrey Riley,
Chief Executive Officer of Synthetic Biologics.
Mr. Riley added, "Based on the results observed in the first
three cohorts, and per our clinical plan, we intend to proceed with
our planned multiple-ascending dose placebo-controlled Phase 1b
study of SYN-004, in which healthy volunteers will receive
increasing doses of SYN-004 over several days. We expect enrollment
into our Phase 1b SYN-004 clinical trial to begin before year-end,
with topline data available during the first quarter of 2015. We
also expect to initiate enrollment in a Phase 2 SYN-004 clinical
trial ahead of schedule during the first quarter of 2015."
SYN-004 is Synthetic Biologics' oral drug candidate designed to
be the first and only treatment intended to prevent C.
difficile infection. Its mechanism of action is to bind with
and neutralize certain common IV beta-lactam antibiotics in the
gut. During 2012, 14.4 million U.S. patients received approximately
117.6 million doses of IV antibiotics[i] that could be inactivated
in the gastrointestinal (GI) tract by SYN-004. SYN-004 is intended
to block the unintended harmful effects of antibiotics within the
GI tract, maintaining the natural balance of the bacterial flora
(gut microbiome), potentially preventing the 1.1 million C.
difficile infections[ii] and 30,000 C. difficile-related
deaths[iii] in the United States
each year.
The U.S. Centers for Disease Control (CDC) has identified C.
difficile as an "urgent public health threat" and occurs mostly
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
annually[iv].
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 gastrointestinal (GI) microflora from the effects of
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 timing
of the enrollment in Synthetic Biologics' clinical trials and data
reports, 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.
Photo -
http://photos.prnewswire.com/prnh/20130522/MM19465LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/synthetic-biologics-announces-positive-topline-results-from-phase-1a-trial-of-syn-004-for-the-prevention-of-c-difficile-infection-300012855.html
SOURCE Synthetic Biologics, Inc.