ROCKVILLE, Md., June 3, 2015 /PRNewswire/ -- Synthetic Biologics,
Inc. (NYSE MKT: SYN), this week presented initial data that support
the Company's development of a platform of therapeutics designed to
protect the microbiome from carbapenems, a class of beta-lactam
antibiotics. The data were presented in a poster at the
115th General Meeting of the American Society of
Microbiology (ASM) in New Orleans,
LA.
Beta-lactam antibiotics are a mainstay in hospital infection
management. However, antibiotics have the potential to cause
unintended harmful effects within the gastrointestinal (GI) tract,
including disruption of the natural balance of the gut microbiome,
leading to 1.1 million C. difficile infectionsi
and 30,000 C. difficile-related deathsii in
the United States each year.
SYN-004 is the Company's candidate therapy designed to degrade
certain intravenous (IV) beta-lactam antibiotics within the GI
tract and maintain the natural balance of the gut microbiome for
the prevention of C. difficile infection,
antibiotic-associated diarrhea (AAD) and secondary
antibiotic-resistant infections. SYN-004 is designed to protect the
microbiome from two classes of beta-lactam antibiotics, penicillins
and cephalosporins.
During ASM, the "Development of Therapeutic Agents that Protect
the Colonic Microflora from Beta-Lactam Antibiotics for the
Prevention of Clostridium difficile Infection" poster
summarized the identification of a novel pipeline beta-lactamase,
P2A, which has the ability to protect the gut microbiome from a
third class of beta-lactam antibiotics, carbapenems. Adding P2A to
the franchise platform expands Synthetic Biologics' intellectual
property claims to cover all three beta-lactam antibiotic classes,
penicillins, cephalosporins, and carbapenems.
"We continue to build our intellectual property portfolio in
order to cover expansion of the beta-lactamase platform that
focuses on protecting the gut microbiome for the prevention
of C. difficile infection and antibiotic-associated
diarrhea," stated Jeffrey Riley,
Chief Executive Officer of Synthetic Biologics. "As a result of
these data we are now exploring the potential of our platform to
protect the microbiome against carbapenems, the third class of
beta-lactam antibiotics. Successful clinical development could
maximize clinician acceptance of our product line upon
commercialization. At the same time, we continue to enroll
participants into a Phase 2a clinical trial of SYN-004, and we are
on track to initiate a proof-of-concept Phase 2b clinical trial of
SYN-004 during the third quarter of 2015."
Second Poster Presented at ASM
Synthetic Biologics also presented a poster titled "Clinical
Evaluation of SYN-004, an Oral Beta-Lactamase Therapy for the
Prevention of Antibiotic-Induced Disruption of Intestinal
Microflora" which summarized Phase 1 clinical data supporting the
SYN-004 program. The following conclusions were presented from the
Phase 1a (40 participants) and Phase 1b (24 participants) clinical
trials of SYN-004:
- SYN-004 was safe and well tolerated at a single dose of up to
750mg and at multiple doses of 300mg four times a day for seven
days
- There were no identified safety or tolerability concerns
attributable to SYN-004; and
- No meaningful levels of SYN-004 were observed in the
bloodstream at the clinical doses evaluated
Webcast of Synthetic Biologics' Microbiome Analyst &
Investor Meeting
A live webcast of the presentations will begin today,
June 3, 2015, at 9:00 a.m. EDT and the webcast is scheduled to
conclude by 11:30 a.m. EDT. The live
webcast of the event will be available via the internet at:
https://tallen.webcasts.com/starthere.jsp?ei=1066312. An archived
webcast will be available at the same website following the
meeting.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical-stage
company focused on developing therapeutics to protect the
microbiome while targeting pathogen-specific diseases. The Company
is developing an oral biologic to protect the gut microbiome from
intravenous (IV) antibiotics for the prevention of C.
difficile infection and an oral statin treatment to reduce the
impact of methane producing organisms on irritable bowel syndrome
with constipation (IBS-C). In addition, the Company is developing a
monoclonal antibody combination for the treatment of Pertussis in
collaboration with Intrexon Corporation (NYSE: XON), and 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 intended treatment
for SYN-004 and its designed protection of the microbiome against
certain beta-lactam antibiotics, including carbapenems, continued
enrollment of the Phase 2a clinical trial, anticipated timing of
the initiation of the Phase 2b clinical trial, continued expansion
of the intellectual property portfolio and the size of the market.
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 ability of
the clinical trials to be performed when anticipated, the ability
of SYN-004 to perform as expected, the results of the clinical
trials and other factors described in Synthetic Biologics' report
on Form 10-K for the year ended December 31,
2014 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 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.
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SOURCE Synthetic Biologics, Inc.