ROCKVILLE, Md. and PARIS, June 10,
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, and Enterome Bioscience SA, a pioneer in
the development of innovative disease management solutions based on
a deep understanding of the gut microbiome, today announced that
they have entered into an agreement to conduct metagenomic research
on the effects of beta-lactam antibiotics on the gastrointestinal
microflora (microbiome) of human patients. As part of this
collaboration, a clinical microbiome study of approximately 100
patients is expected to begin next month. Research findings should
provide important insights as Synthetic Biologics advances the
development of SYN-004, which is intended to protect the gut
microbiome from the effects of intravenous (IV) beta-lactam
antibiotics, and in particular to prevent C. difficile
(C. diff) infections. Phase Ia and Ib clinical trials of
Synthetic Biologics' SYN-004 are scheduled to begin later this
year.
The Enterome microbiome study, scheduled for completion in the
second half of 2014, is expected to provide a better understanding
of the harmful effects of beta-lactam antibiotics on the gut
bacterial community. The goal is to establish a "fingerprint" of
the damage caused by beta-lactam antibiotics, thus yielding a panel
of bacterial biomarkers that can be leveraged for diagnostic
purposes. This novel study should clearly define the impact of
beta-lactam antibiotics on the natural bacterial diversity of the
gut microbiome. Changes in the gut microbiome have been related to
multiple diseases, including C. diff infections,
antibiotic-associated diarrhea, obesity, diabetes and other
metabolic diseases. This study will utilize Enterome's
state-of-the-art shotgun metagenomic sequencing technology to
profile the human gut microbiome.
"We are pleased to establish this collaboration with Enterome, a
pioneer in the development of biomarkers and therapies for diseases
of the gut microbiome," stated Jeffrey
Riley, CEO of Synthetic Biologics. "Findings from this study
should support our C. diff therapeutic program, which
focuses on protecting and maintaining the balance of bacterial
microflora in the gut, while also establishing our presence in
Europe."
Synthetic Biologics' lead anti-infective product candidate,
SYN-004, is the first therapy designed to neutralize IV antibiotics
in the gut, and is intended to protect and maintain the balance of
bacterial flora in the gastrointestinal tract, to prevent the
devastating effects of C. diff. The U.S. Centers for Disease
Control and Prevention (CDC) has classified C. diff as an
"urgent public health threat"i, surpassing
Methicillin-resistant Staphylococcus aureus (MRSA) as the
number one hospital-acquired infection in the United States. C. diff is a
multidrug-resistant bacterium that infects 1.1 million U.S.
patients annuallyii. In the U.S., patients with C.
diff are hospitalized an estimated 3.6-7 extra
daysiii, costing more than $8.2
billioniv.
"The signing of this agreement with Synthetic Biologics is
another important corporate milestone for Enterome. I am very
pleased that our pioneering approach to understanding the linkage
between changes in the gut microbiome and disease has convinced
Synthetic Biologics to work with us on such an important
personalized medicine project. It is clear that new diagnostic
solutions are needed to properly address the growing problem of
antibiotic-induced dysbiosis and associated hospital-acquired
bacterial infections," stated Pierre Belichard, CEO of Enterome.
"Tailoring the use of anti-infective treatments based on microbiome
profiling is beginning to show great promise as a way to address
the management of infectious diseases."
"Comparing Enterome's technology to other genomic analyses of
gut microbiome is like comparing a Quad Full High definition color
resolution TV to resolution of an analog black & white TV,"
added Mr. Riley.
About SYN-004 Clinical Development
Synthetic Biologics is developing SYN-004, a novel second
generation oral enzyme drug candidate, to be co-administered with
commonly used IV beta-lactam antibiotics and is intended to protect
the gastrointestinal microflora (microbiome) from the harmful
effects of such antibiotics, thus potentially preventing C.
diff infections. Planned next steps for SYN-004 include: 1)
initiation of a 28-day bridging toxicology study in June 2014; 2) filing of an Investigational New
Drug (IND) application to initiate Phase Ia and Ib clinical trials
in the second half of 2014, with preliminary topline data expected
by year-end 2014; and, 3) initiation of a Phase II efficacy study
is expected to begin in the first half of 2015.
About Enterome Bioscience SA
Enterome is pioneering the development of innovative disease
management solutions based on a deep understanding of the gut
microbiome. Understanding and modifying the changes that occur in
the gut microbiome during disease and in response to therapeutic
interventions represent an entirely new and untapped opportunity to
impact medicine.
Initially Enterome is using its expertise and proprietary
technologies to develop novel diagnostic products to support
patient stratification, personalized therapies and the clinical
development of new drugs for the treatment of microbiome-related
diseases such as inflammatory bowel diseases and metabolic diseases
(diabetes and obesity). Enterome's unique Metagenotyping® process
has allowed it to develop biomarkers for treatment response
prediction, disease activity monitoring and as potential companion
diagnostics.
The company was established in 2012 in Paris, France, and has raised a total of
€17.5m from leading venture capital investors (Seventure, Omnes
Capital & Lundbeckfond Ventures) and two strategic investors
(Danone & Shire).
www.enterome.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 anticipated timing
and results of the Synthetic Biologics' clinical trials, studies
and development efforts and the expected benefits of 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,
studies 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' candidates for the
prevention and treatment of infectious 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 U.S. Centers for Disease Control Web site:
http://www.cdc.gov/drugresistance/threat-report-2013/pdf/ar-threats-2013-508.pdf#page=51
Accessed: March 26, 2014.
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 (APIC) National Prevalence Study of
Clostridium difficile in U.S. Healthcare Facilities.
November 11, 2008.
http://hospitalacquiredinfections.blogspot.com/2008/12/november-11-2008-association-for.html.
iv Agency for Healthcare Research and Quality.
Healthcare and Cost Utilization Project. Statistical Brief #124.
Clostridium difficile Infections (CDI) in Hospital Stays,
2009. January 2012. Available at
http://www.hcup-us.ahrq.gov/reports/statbriefs/sb124.pdf.
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SOURCE Synthetic Biologics, Inc.