ROCKVILLE, Md., Aug. 28, 2014 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a developer of novel
anti-infective biologic and drug candidates targeting specific
pathogens that cause serious infections and diseases, and FUJIFILM
Diosynth Biotechnologies UK Limited (Fujifilm), announced today
confirmation of exceptional results from the initial phase of cGMP
manufacturing of SYN-004, Synthetic Biologics' proprietary oral
beta-lactamase enzyme for the prevention of Clostridium
difficile (C. difficile) infections.
The initial 750-liter cGMP production run on Fujifilm's pAVEway™
platform yielded an unprecedented 5.5 kilograms of >95% pure
SYN-004 active pharmaceutical ingredient (API) drug
substance, which will be used to support Synthetic Biologics'
planned Phase I and II clinical trials, and continued research and
development studies.
SYN-004 is believed to be the first and only therapy designed to
neutralize intravenous (IV) antibiotics in the gut. It is intended
to protect and maintain the balance of bacterial flora in the
gastrointestinal (GI) tract, or gut microbiome, and to potentially
prevent the devastating effects of C. difficile infection.
Research continues to demonstrate that protection of the microbiome
plays an increasingly important role in the prevention of a variety
of GI, metabolic and CNS disorders. The U.S. Centers for Disease
Control and Prevention (CDC) have classified C. diff as an
"urgent public health threat", surpassing Methicillin-resistant
Staphylococcus aureus (MRSA) as the number one
hospital-acquired infection in the United
States. C. difficile is a multidrug-resistant
bacterium that infects 1.1 million U.S. patients
annually,1 and 30,000 patients die with a C.
difficile infection annually2.
"We are extremely impressed by the quality, quantity and
efficiency of the initial SYN-004 API manufacturing work by
Fujifilm," stated Jeffrey Riley,
Chief Executive Officer of Synthetic Biologics. "Fujifilm not only
exceeded our yield expectations, but also provided exemplary
customer service through its diligent approach and skillful
execution in developing the cGMP process for SYN-004."
Mr. Riley concluded, "Importantly, with a solid new GMP
manufacturing process, Synthetic Biologics remains on schedule to
file an Investigational New Drug (IND) application for SYN-004, and
initiate Phase Ia and Ib clinical studies for the prevention of
C. difficile infection in the second half of 2014.
Preliminary Phase I topline data is expected by year-end 2014, and
a Phase II efficacy study of SYN-004 is planned to begin in the
first half of 2015."
The GMP manufacturing process was initiated after a successful
evaluation by Fujifilm that produced high yielding cell lines that
exhibited consistent biological activity of SYN-004. Fujifilm
successfully improved SYN-004 expression titers by greater than
25-fold (14 grams of SYN-004 per liter of culture broth), compared
to the Bacillus platform previously employed for SYN-004's
first-generation predecessor. Fujifilm's pAVEway™ platform (an
E. coli system) utilizes proprietary expression vectors
harboring palindromic DNA looping to provide tightly controlled
gene expression, which can enable very high expression
levels. The newly developed, single chromatography column
purification process reproducibly yielded 40-50% SYN-004 drug
substance recovery at purity levels great than 95%, another marked
manufacturing improvement over the previous purification
process.
Steve Bagshaw, Chief Executive
Officer of FUJIFILM Diosynth Biotechnologies said, "We are pleased
to demonstrate the remarkable versatility of our pAVEway™
expression system, and support Synthetic Biologics' clinical
development of its SYN-004 product. We look forward to a productive
relationship with Synthetic Biologics as its API supplier."
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.
About FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies UK Limited is an industry
leading biologics Contract Development and Manufacturing
Organization. FUJIFILM Diosynth Biotechnologies has extensive
experience in the development and manufacturing of recombinant
proteins, vaccines, monoclonal antibodies, among other large
molecules expressed in a wide array of microbial, mammalian, and
insect systems. The company offers a comprehensive list of services
from microbial and mammalian cell line development, including its
proprietary pAVEway™ system, to process development, analytical
development, clinical and commercial manufacturing. FUJIFILM
Diosynth Biotechnologies is also located in Research Triangle Park, NC, USA as FUJIFILM
Diosynth Biotechnologies U.S.A.,
Inc. Both sites have been FDA-approved for the production of
commercial biologic products.
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 effects
and potential impact of SYN-004, the timing of initiation of the
Phase Ia and Ib clinical studies, the preliminary Phase I topline
data and initiation of Phase II efficacy study and the expected
size of the market for C. diff therapeutics. 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, our inability to timely commence or complete the clinical
trials consistent with our current expectations and otherwise
demonstrate the ability of SYN-004 to have a significant impact on
mitigating the effects of C. difficile, our ability to successfully
manufacture cGMP product, receive regulatory approvals for or to
commercialize a new product candidate to prevent C. diff infection
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.
1 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.
2 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.