ROCKVILLE, Md., July 7, 2016 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a clinical stage company focused
on developing therapeutics to protect the gut microbiome while
targeting pathogen-specific diseases, announced today that the
United States Adopted Names Council (USAN) of the American Medical
Association has approved the use of "ribaxamase" (Rye-bak'-sa-mase)
for Synthetic Biologics' SYN-004. Ribaxamase is the Company's Phase 2
development 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.
Synthetic Biologics recently reported positive results from two
Phase 2a clinical trials demonstrating a correlation of the 150 mg
dose of ribaxamase with the degradation of residual IV ceftriaxone
alone, and in the presence of the proton pump inhibitor (PPI),
esomeprazole, to levels that were near or below detectable in the
intestinal chyme of healthy participants with functioning
ileostomies. A Phase 2b proof-of-concept, randomized,
placebo-controlled clinical trial is currently underway to evaluate
the ability of ribaxamase 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.
"The approval of the generic name ribaxamase for SYN-004 by USAN is a defining
milestone for Synthetic Biologics. Ribaxamase represents a newly
created and innovative first-in-class drug designed to protect the
naturally occurring gut microbiome from the unintended consequences
of antibiotic use," said Jeffrey
Riley, President and Chief Executive Officer. "By degrading
certain IV beta-lactam antibiotics before they reach the
gastrointestinal (GI) tract, ribaxamase may not only prevent the
onset of CDI and AAD, but has the potential to be an instrumental
tool for preventing the emergence of antibiotic resistance in
organisms which comprise the gut microbiome. We are excited for the
continued clinical development of ribaxamase and look forward to
sharing our progress including announcing results from our ongoing
global Phase 2b proof-of-concept clinical trial."
Synthetic Biologics also announced that an abstract has been
accepted for oral presentation at ANAEROBE 2016 taking place from
July 11-14 at the Sheraton Downtown
Nashville Hotel in Nashville, TN.
The presentation is expected to take place during Session 10:
Bacterial Replacement Therapy and is scheduled for the afternoon on
Wednesday, July 13, 2016.
Presentation Title: Ribaxamase: A Pioneering Therapeutic
to Protect the Microbiome from Antibiotic-Mediated Damage
Authors: Connelly, S1*, Bristol, JA1, Hubert,
S1, Hasan, NA2, Subramanian, P2,
Furlan-Freguia, C1, Sliman, J1, Kaleko,
M1; 1Synthetic Biologics, Inc., Rockville, MD; 2CosmosID, Inc.,
Rockville, MD, USA
About Ribaxamase
Ribaxamase is a first-in-class oral enzyme designed to protect
the gut microbiome from disruption caused by commonly used IV
beta-lactam antibiotics. Ribaxamase has demonstrated in clinical
trials that it is not systemically absorbed, does not interfere
with the efficacy of IV beta-lactam antibiotics and, by protecting
the patient's native gut microbiome, may prevent the overgrowth and
associated infection with Clostridium difficile as well as
antibiotic-associated diarrhea. Ribaxamase has the potential to
protect patients from CDI and AAD which could result in shortened
hospital stays, diminished morbidity and mortality and a reduction
of antibiotic resistance and costs associated with the inadvertent
consequences of IV beta-lactam antibiotic use.
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) 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 and antibiotic-associated diarrhea
(AAD). 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 ribaxamase and SYN-010,
including the capacity of ribaxamase 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, the ability of ribaxamase to
not only prevent the onset of CDI and AAD, but its potential to be
an instrumental tool for preventing the emergence of antibiotic
resistance in organisms which comprise the gut microbiome, the
continued clinical development of ribaxamase and results from the
ongoing global Phase 2b proof-of-concept clinical trial, and the
potential of ribaxamase to result in shortened hospital stays,
diminished morbidity and mortality and a reduction of antibiotic
resistance and costs associated with the inadvertent consequences
of IV beta-lactam antibiotic use. 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 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, 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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