ROCKVILLE, Md., Sept. 8, 2014 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a biotechnology company developing
novel anti-infective biologic and drug programs targeting specific
pathogens that cause serious infections and diseases, announced
today that data from its novel SYN-005 program for the treatment of
Pertussis were highlighted in an oral presentation on September 7th by Jennifer
Maynard, Ph.D., at the 54th Interscience
Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in
Washington, D.C. SYN-005 combines
two highly synergistic humanized monoclonal antibodies (mAbs)
designed to target and neutralize pertussis toxin.
Pertussis is a highly contagious disease caused by the bacteria
Bordetella pertussis (B. pertussis) with symptoms that
include severe coughing and subsequent breathing difficulties.
Antibiotic use does not have a major effect on the disease course
because, while it can eliminate the B. pertussis bacteria
from the respiratory tract, it does not neutralize pertussis toxin.
This secreted toxin is a major cause of disease virulence as it
paralyzes the immune system, causes the white blood cell count to
increase (sometimes to levels that block blood flow through the
lungs) and predisposes infants to severe pneumonia.
Pertussis can be fatal in infants; therefore, attacking
pertussis toxin in infants is an urgent unmet medical need.
According to the World Health Organization, B. pertussis
causes an estimated 300,000 deaths worldwide each year, primarily
among young, unvaccinated infants.
Dr. Maynard's presentation described the design and evaluation
of the mAbs that comprise SYN-005. The two humanized mAbs were
protective when used both individually and in combination in a
murine model of respiratory Pertussis. SYN-005-treated animals
continued to gain weight, demonstrated reduced bacterial
colonization in the lungs, and did not experience the rise in the
white blood cell count that is characteristic of the disease.
SYN-005 also was shown to be efficacious in a recently
described, highly relevant non-human primate Pertussis model.
Treatment of infected animals halted the rise in the white blood
cell count and accelerated the resolution of coughing as well as
the clearance of pertussis bacteria.
Mike Kaleko, M.D., Ph.D., Senior
Vice President of Research & Development for Synthetic
Biologics stated, "We are pleased to have the opportunity to
showcase our Pertussis program at the ICAAC meeting. The in
vivo studies and, in particular, the efficacy data in the
non-human primates demonstrate the exceptional potential for
SYN-005 to treat Pertussis and diminish the morbidity and mortality
of this devastating disease in infants. Synthetic Biologics remains
on track to file an Investigational New Drug (IND) application and
initiate a Phase I clinical trial during the first half of 2015 and
has requested Orphan Drug designation for SYN-005 in this
indication."
Dr. Maynard is an Associate Professor at The University of Texas at Austin's McKetta Department
of Chemical Engineering. Her oral presentation on Synthetic
Biologics' SYN-005 was part of the "Neonatal Infections and the
Case for Maternal Immunization" session at ICAAC.
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 design of SYN-005,
the potential for SYN-005 to treat Pertussis and diminish
the morbidity and mortality and the planned IND filing and Phase I
clinical trial. 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, the additional clinical studies and results not meeting
expectations, the inability to commence and complete clinical
trials when expected 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.
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SOURCE Synthetic Biologics, Inc.