ROCKVILLE, Md., Aug. 5, 2014 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a developer of novel
anti-infective biologic and drug candidates targeting specific
pathogens that cause serious infections and diseases, today
announced that, with a new multi-service agreement in place, the
Company is on track to initiate Phase Ia and Ib clinical trials of
SYN-004 for the prevention of Clostridium difficile (C.
difficile) during the fourth quarter of 2014. The Company has
entered into an agreement with Evonik for oral formulation
development, analytical services, and clinical drug manufacturing
in accordance to GMP guidelines, of the Company's proprietary oral
beta-lactamase enzyme, SYN-004, for use in the planned clinical
trials. Evonik plans to formulate and encapsulate enterically
coated SYN-004 for oral delivery using material generated by
Synthetic Biologics' API manufacturer FUJIFILM Diosynth
Biotechnologies UK Limited.
SYN-004 is designed as the first and only prophylactic treatment
intended to prevent the development of C. difficile
infections, by binding with and neutralizing certain intravenous
(IV) beta-lactam antibiotics in the gut. SYN-004 is intended to
block the effects of antibiotics within the gastrointestinal tract,
maintaining the natural balance of bacterial flora (the gut
microbiome), potentially preventing the 1.1 million C.
difficile infections in the U.S. each year1.
"SYN-004 has the potential to have a significant impact on
mitigating the effects of C. difficile, a major public
health issue, and we are thrilled to be advancing rapidly toward
the clinic with our novel and differentiated approach," stated
Jeffrey Riley, Chief Executive
Officer of Synthetic Biologics. "While we await the topline results
of the ongoing toxicology study, we are pleased to have begun
working with our strategic partner Evonik, to optimize formulation
variables and manufacture GMP clinical trial drug supply to support
our planned human studies, once our IND is in place."
The U.S. Centers for Disease Control and Prevention (CDC) has
classified harmful and potentially deadly C. difficile as an
"urgent public health threat," surpassing Methicillin-resistant
Staphylococcus aureus (MRSA) as the number one
hospital-acquired infection in the United
States.
Prior to initiating cGMP manufacturing of SYN-004 capsules,
Evonik successfully formulated and manufactured nonclinical trial
material for the ongoing canine toxicology study, from which
Synthetic Biologics expects to report topline results next month.
With these critical milestones underway, the Company remains on
schedule to file an Investigational New Drug (IND) application for
SYN-004, and intends to initiate Phase Ia and Ib clinical studies
in the fourth quarter of 2014. Preliminary Phase I topline data is
expected by year-end 2014, and a Phase II efficacy study of SYN-004
is planned to begin in the first half of 2015.
About Evonik
Evonik, the creative industrial group from Germany, is one of the world leaders in
specialty chemicals. Profitable growth and a sustained increase in
the value of the company form the heart of Evonik's corporate
strategy. Its activities focus on the key megatrends health,
nutrition, resource efficiency and globalization. Evonik benefits
specifically from its innovative prowess and integrated technology
platforms. Evonik is active in over 100 countries around the world.
In fiscal 2013, more than 33,500 employees generated sales of
around €12.7 billion and an operating profit (adjusted EBITDA) of
about €2.0 billion. For more information, please visit Evonik's
website at www.evonik.com.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology
company focused on the development of novel anti-infective biologic
and drug candidates targeting specific pathogens that cause serious
infections and diseases. The Company is developing an oral biologic
to protect the gastrointestinal microflora from the effects of IV
antibiotics for the prevention of Clostridium difficile (C.
difficile) infection, an oral treatment to reduce the impact of
methane producing organisms on constipation-predominant irritable
bowel syndrome (C-IBS), a series of monoclonal antibodies for the
treatment of Pertussis and Acinetobacter infections, and a
biologic targeted at the prevention and treatment of a root cause
of a subset of IBS. In addition, the Company is developing an 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 intended effects
and potential impact of SYN-004, the timing of initiation of the
Phase Ia and Ib clinical studies, the preliminary Phase I topline
data and initiation of Phase II efficacy study and the expected
size of the market for C. diff therapeutics. 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, our inability to timely commence or complete the clinical
trials consistent with our current expectations and otherwise
demonstrate the ability of SYN-004 to have a significant impact on
mitigating the effects of C. difficile, our ability to successfully
manufacture cGMP product, receive regulatory approvals for or to
commercialize a new product candidate to prevent C. diff infection
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.
1This 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.