ROCKVILLE, Md., May16, 2016
/PRNewswire/ -- Synthetic Biologics, Inc. (NYSE MKT: SYN), a
clinical stage company focused on developing therapeutics to
protect the gut microbiome, announced positive topline results from
the second Phase 2a open-label clinical trial of SYN-004, the
Company's candidate designed to protect the gut microbiome from the
unintended 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 antibiotic-resistant organisms. Results from 14
participants who completed this clinical trial were analyzed to
assess the ability of the 150 mg dose of SYN-004 to degrade
ceftriaxone when administered alone and with the proton pump
inhibitor (PPI), esomeprazole.
Consistent with previously reported results from the first Phase
2a clinical trial, the second Phase 2a trial demonstrated that the
150 mg dose of SYN-004 degraded residual IV ceftriaxone alone, and
in the presence of a PPI, to levels that were near or below
detectable in the intestinal chyme of healthy participants with
functioning ileostomies. In addition, ceftriaxone plasma
concentrations in study participants were very similar in the
presence or absence of an oral PPI. The 150 mg dose strength of
SYN-004 was well tolerated by all participants in this clinical
trial.
"These topline data support the hypothesis that SYN-004 has the
capacity to degrade residual IV ceftriaxone, in the presence of a
PPI, thereby preserving the balance of the gut microbiome with the
intent to prevent CDI, AAD and the emergence of
antibiotic-resistant organisms, without affecting the antibiotic
level in the bloodstream necessary for the treatment of primary
infection," said Jeffrey Riley,
President and Chief Executive Officer of Synthetic Biologics. "Our
Phase 2b proof-of-concept, randomized, placebo-controlled clinical
trial has enrolled over 210 patients to evaluate the ability of
SYN-004 to prevent CDI and AAD in patients hospitalized with a
lower respiratory tract infection and receiving IV ceftriaxone. An
interim analysis of blinded data performed by an independent data
monitoring committee is expected in summer of 2016."
Synthetic Biologics also announced that two abstracts have been
accepted for poster presentation at ASM Microbe 2016. Both posters
will be available for viewing in Halls A and B at the Boston
Convention & Exhibition Center on Friday, June 17, from 12:30 to 2:30 p.m. (EDT), as part of the
"Experimental Therapeutics" session.
Poster: 456
Title: SYN-004, an Oral β-Lactamase to Prevent
Clostridium difficile, Degrades Ceftriaxone Excreted in the
Human Intestine in Phase 2a Trials
Authors: J. F.
Kokai-Kun1, T. Roberts1, E.
Sicard2, M. Rufiange2, R.
Fedorak3, C. Carter3, O.
Coughlin1, H. Whalen1, K.
Gottlieb1, J. Sliman1; 1Synthetic
Biologics, Inc., Rockville, MD,
2Algorithme Pharma, Laval,
QC, Canada,
3Univ. of Alberta/Alberta Hlth. Service, Edmonton, AB, Canada
Poster: 446
Title: Development of Orally-Delivered Therapeutics to
Protect the Gut Microbiome from Antibiotic-Mediated Damage
Authors: S. Connelly1, C. Freguia1, T.
Parsley2, N. Hasan3, P.
Subramanian3, M. Kaleko1;
1Synthetic Biologics, Inc., Rockville, MD, 2SynPhaGen, LLC.,
Rockville, MD,
3CosmosID, Inc., Rockville,
MD
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical stage
company developing therapeutics to protect the gut microbiome while
targeting pathogen-specific diseases. The Company's lead candidates
in Phase 2 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 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 and antibiotic-associated diarrhea
(AAD). In collaboration with Intrexon Corporation, 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 the timing of the interim analysis
and the potential benefits of SYN-004 and SYN-010,
including the capacity of SYN-004 to degrade residual IV
ceftriaxone, in the presence of a PPI, thereby preserving the
balance of the gut microbiome for the prevention of CDI, AAD and
the emergence of antibiotic-resistant organisms, without affecting
the antibiotic level in the bloodstream intended for the treatment
of primary infection. 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' 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, 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, 2015 and its other
filings with the SEC, including subsequent periodic reports on
Forms 10-Q and 8-K. 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.