ROCKVILLE, Md., April 19, 2017 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a late-stage clinical company
developing therapeutics that preserve the microbiome to protect and
restore the health of patients, today announced positive data for
SYN-005, the Company's orphan drug program for the prevention and
treatment of pertussis (whooping cough). SYN-005 combines two
highly synergistic humanized monoclonal antibodies (hu1B7 and
hu11E6) to target and potentially inactivate the life-threatening
pertussis toxin that causes disease symptoms.
To assess the potential of SYN-005 to prevent pertussis, a
non-human primate study was designed to determine if administration
of hu1B7, one component of SYN-005, at two days of age could
protect animals from a subsequent pertussis infection. Control
animals (n=6), infected with Bordetella pertussis (B.
pertussis) at five weeks of age, demonstrated marked elevations
in white blood cell counts and most exhibited behavioral signs of
pertussis, including coughing and diminished activity. In contrast,
the experimental animals (n=7), who were treated with hu1B7 at two
days of age and then infected five weeks later, had significantly
lower peak white blood cell counts (p=0.004) that remained within
the normal range or were only slightly elevated. Importantly, all
seven of the animals that received prophylactic hu1B7 appeared
healthy and none exhibited any behavioral signs of pertussis.
An additional animal received hu1B7 at two days of age; however,
infection with B. pertussis was delayed to a time point when
hu1B7 was no longer detectable in the blood. As expected, in the
absence of hu1B7, the animal developed a high white blood cell
count and behavioral signs of pertussis. These data further support
that protection from pertussis was, in fact, due to hu1B7.
Building on this early success, the Company has initiated
preclinical testing of a modified version of hu1B7 that has the
potential to extend the plasma half-life and substantially reduce
the required dose of SYN-005.
The Company previously reported that SYN-005 was highly
efficacious as a therapeutic in non-human primates infected with
B. pertussis. The current study expands the potential
clinical utility beyond therapy to also include prophylaxis.
Pertussis, more commonly known as whooping cough, is a highly
contagious disease caused by the bacteria Bordetella pertussis
(B. pertussis). The disease can prove fatal in infants and
children, with symptoms of infection including chronic coughing and
subsequent breathing difficulties. According to the World Health
Organization, there are approximately 50 million worldwide cases of
whooping cough each year, leading to an estimated 300,000 deaths,
primarily among young, unvaccinated infants. Antibiotic use does
not have a major effect on the course of pertussis because, while
antibiotics may eliminate the B. pertussis bacteria from the
respiratory tract, they do not neutralize the pathogenic pertussis
toxin, a key virulence factor.
"There is a pressing need for new and innovative agents to
address the re-emergence of pertussis as a rising global health
concern, particularly in the developing world where the mortality
rate for at-risk newborns is highest," said Jeffrey Riley, President and Chief Executive
Officer. "Positive results from this non-human primate study
suggest that SYN-005 may be able meet this need by preventing
pertussis infection among high risk individuals. These data, along
with those from our earlier therapeutic studies, provide strong
support for advancing SYN-005 to clinical trials for both the
prevention and treatment of pertussis, especially in newborns."
Synthetic Biologics is developing SYN-005 through its Exclusive
Channel Collaboration with Intrexon Corporation (NYSE: XON) and
academic researchers led by Dr. Jennifer
Maynard, associate professor in the McKetta Department of
Chemical Engineering at The University of
Texas at Austin, to prevent the development of pertussis in
at-risk newborns and to target and neutralize the pertussis toxin
in order to reduce morbidity and mortality in infected infants. In
2015, The Bill & Melinda Gates Foundation awarded a grant to UT
Austin to generate preclinical
proof-of-concept data to test the hypothesis that antibody
administration at birth may have a role in the prevention of
pertussis. Dr. Maynard is principal investigator of The Gates
Foundation grant and this prophylaxis study.
"We are greatly encouraged by these results, which clearly
demonstrate hu1B7, a humanized anti-pertussis toxin monoclonal
antibody, protected neonatal primates from developing pertussis for
at least five weeks," said Dr. Jennifer
Maynard. "These data give us increased confidence that
pertussis prophylaxis using hu1B7 may be a viable option to protect
newborns for several months after birth when the risk of pertussis
mortality is highest."
Synthetic Biologics also announced that two abstracts have been
accepted for presentation at ECCMID 2017 and ESPID 2017. Dr.
Jennifer Maynard will present a
poster at ECCMID and a talk at ESPID.
European Congress of Clinical Microbiology and Infectious
Diseases (ECCMID)
April 22,
2017 from 15:30 p.m. –
16:30 p.m. CEST
Poster: 0464
Title: Monoclonal Antibody
Administration Provides Five Weeks of Prophylaxis in Newborn
Baboons: PoC for Passive Immunization to Protect Infants in the
Developing World
Authors: J.A.
Maynard1, A. Nguyen1, R.F. Wolf2, J.F. Papin2, S. Connelly3,
M. Kaleko3;
1University of Texas at Austin,
Austin, TX,
2University of Oklahoma Health
Science Center, Oklahoma City,
OK, 3Synthetic Biologics, Inc., Rockville, MD, USA
European Society for Pediatric Infectious Diseases
(ESPID)
May 25, 2017 from
14:40 p.m. – 16:10 p.m. CEST
ESPID Symposium 2: Prevention of Pertussis in Infants – The Ongoing
Challenge
Title: Antibody Administration Effectively Treats Pertussis
in a Baboon Disease Model and Provides Five Weeks of Pertussis
Prophylaxis in Newborn Baboons
Authors: J.A.
Maynard1, A. Nguyen1, R.F. Wolf2, J.F. Papin2, S. Connelly3,
M. Kaleko3;
1University of Texas at Austin,
Austin, TX,
2University of Oklahoma Health
Science Center, Oklahoma City,
OK, 3Synthetic Biologics, Inc., Rockville, MD, USA
About SYN-005
SYN-005 combines two highly synergistic humanized monoclonal
antibodies (mAbs) to target and potentially inactivate the
life-threatening pertussis toxin. In preclinical therapeutic and
prophylactic studies, SYN-005 was associated with significant
reductions in white blood cell count and bacterial loads in
non-human primate and murine animal models. Synthetic Biologics
further strengthened its intellectual property position around
pertussis antibodies with additional patent filings, including the
granting of a U.S. Composition of Matter patent for SYN-005. In
September 2014, the U.S. Food and
Drug Administration (FDA) granted Orphan Drug designation for
SYN-005 for the treatment of pertussis.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a late-stage
clinical company developing therapeutics designed to preserve the
microbiome to protect and restore the health of patients. The
Company's lead candidates poised for Phase 3 development are: (1)
SYN-010 which is intended to reduce the impact of methane producing
organisms in the gut microbiome to treat an underlying cause of
irritable bowel syndrome with constipation (IBS-C), and (2) SYN-004
(ribaxamase) which is designed to protect the gut microbiome from
the effects of certain commonly used intravenous (IV) beta-lactam
antibiotics for the prevention of C. difficile infection
(CDI), antibiotic-associated diarrhea (AAD) and the emergence of
antimicrobial resistance (AMR). The Company is also developing
preclinical stage monoclonal antibody therapies for the prevention
and treatment of pertussis and novel discovery stage
biotherapeutics for the treatment of phenylketonuria (PKU). For
more information, please visit Synthetic Biologics' website at
www.syntheticbiologics.com.
This release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. 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, and include statements
regarding positive results from the non-human primate study
suggesting that SYN-005 may be able meet a pressing need by
preventing the development of pertussis in high risk individuals,
the confidence that pertussis prophylaxis using hu1B7 may be
a viable option to protect newborns for several months after birth
when the risk of pertussis mortality is highest, the size of the
market, and the potential benefits of SYN-004 and
SYN-010. These forward-looking statements are based on
management's expectations and assumptions as of the date of this
press release and are subject to a number of risks and
uncertainties, many of which are difficult to predict that could
cause actual results to differ materially from current expectations
and assumptions from those set forth or implied by any
forward-looking statements. Important factors that could
cause actual results to differ materially from current expectations
include, among others, Synthetic Biologics' product
candidates demonstrating safety and effectiveness, as well as
results that are consistent with prior results, Synthetic
Biologics' ability to initiate clinical trials and if initiated, to
complete them on time and achieve desired results and benefits,
Synthetic Biologics' ability to successfully design a protocol and
a corresponding statistical analysis plan to support the execution
of its pivotal clinical trials, Synthetic Biologics'
clinical trials continuing enrollment as expected, Synthetic
Biologics' ability to obtain regulatory approvals for
commercialization of product candidates or to comply with ongoing
regulatory requirements, regulatory limitations relating to
Synthetic Biologics' ability to promote or commercialize its
product candidates for specific indications, acceptance of its
product candidates in the marketplace and the successful
development, marketing or sale of Synthetic Biologics' products by
competitors that render Synthetic Biologics' products obsolete or
non-competitive, Synthetic Biologics' ability to maintain its
license agreements, the continued maintenance and growth of
Synthetic Biologics' patent estate, Synthetic Biologics
becoming and remaining profitable, Synthetic
Biologics' ability to establish and maintain
collaborations, Synthetic Biologics' ability to obtain
or maintain the capital or grants necessary to fund its research
and development activities, a loss of any of Synthetic
Biologics' key scientists or management
personnel, and other factors described in Synthetic
Biologics' Annual Report on Form 10-K for the year ended
December 31, 2016 and its 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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