ROCKVILLE, Md., Jan. 5, 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 topline
data from its Phase 2b clinical trial for SYN-004 (ribaxamase), the
Company's first-in-class oral enzyme designed to protect the gut
microbiome from disruption caused by certain intravenous (IV)
beta-lactam antibiotics.
The study, a randomized, double-blind, placebo controlled trial
of 412 patients, met its primary endpoint of significantly reducing
C. difficile Infection (CDI). Preliminary analysis of the
data indicated seven confirmed cases of CDI in the placebo group
compared to two cases in the ribaxamase treatment group. Patients
receiving ribaxamase achieved a 71.4% relative risk reduction
(p-value=0.045) in CDI rates compared to patients receiving
placebo. Adverse events reported during this trial were comparable
between treatment and placebo arms.
Synthetic Biologics is also in the process of analyzing data
from several exploratory endpoints that were designed to evaluate
ribaxamase's ability to protect the gut microbiome from
colonization by opportunistic bacteria such as C. difficile
and other antibiotic-resistant pathogens. Preliminary analysis of
the data demonstrated a significant reduction in new colonization
by vancomycin-resistant enterococci (VRE) for patients receiving
ribaxamase compared to placebo (p-value=0.0002). With agreement
from the FDA, the study included a secondary endpoint to assess
ribaxamase's capacity to decrease the incidence of
antibiotic-associated diarrhea from all causes. Preliminary
analysis of the data suggested a trend towards such a reduction
(p-value=0.13), which was due, for the most part, to the reduction
of CDI.
These data are consistent with ribaxamase's mechanism of action
designed to protect and preserve the natural balance of the gut
microbiome from the unintended effects of IV antibiotic use. The
Company expects to share additional results from these exploratory
endpoints as they become available later this year, including
results focused on ribaxamase's ability to prevent the emergence of
antimicrobial resistance in the gut microbiome.
"These trial results provide a compelling demonstration of the
potential of ribaxamase to help address the serious health impacts
associated with CDI and infections from other opportunistic
bacteria resulting from dysbiosis of the gut microbiome," said
Joseph Sliman, MD, SVP, Clinical and
Regulatory Affairs. "More than 453,0001 patients are
diagnosed with CDI annually in the U.S., resulting in approximately
29,0001 deaths as well as significant and sometimes
prolonged illness. Ribaxamase has the potential to shorten hospital
stays, diminish morbidity and mortality and reduce the emergence of
antibiotic-resistant organisms in the gut microbiome by protecting
patients from primary C. difficile infection resulting from
IV antibiotic use."
In addition to causing significant suffering and mortality, CDI
adds an estimated economic burden of nearly $1.5 billion1 to the healthcare system
each year, which could potentially be reduced with an effective
therapeutic.
"The reduction in the relative risk of CDI represents a
significant milestone in the clinical development of ribaxamase and
we believe provides further validation for our approach to
advancing cutting edge microbiome science," said Jeffrey Riley, President and Chief Executive
Officer. "These findings also help further our goals to bring the
first ever microbiome-focused therapeutic to patients and to help
illuminate the potential of this drug class to address serious
diseases and public health concerns. We expect to share additional
data from exploratory endpoints in the coming months and look
forward to continuing ongoing and productive discussions with both
the FDA and CDC on the protocol for Phase 3 pivotal trials for
ribaxamase."
Synthetic Biologics is also continuing to prepare for the
initiation of pivotal Phase 2b/3 clinical trials for SYN-010, the
Company's proprietary, modified-release formulation of lovastatin
lactone designed to treat the underlying cause of irritable bowel
syndrome with constipation (IBS-C).
Presentation Planned for Biotech Showcase 2017
Conference
Date: Monday, January 9,
2017
Time: 9:30 a.m. (PT) /
12:30 p.m. (ET)
Location: Hilton San Francisco Union Square, San Francisco, CA
A live webcast of Synthetic Biologics' presentation may be
accessed by logging onto the internet at
https://event.webcasts.com/viewer/event.jsp?ei=1130367. After the
presentation, a replay will be archived and accessible for 90 days
at the same website.
About SYN-004 (ribaxamase) and the Phase 2b Study
SYN-004 (ribaxamase) is a first-in-class oral enzyme designed to
degrade certain IV beta-lactam antibiotics within the GI tract and
maintain the natural balance of the gut microbiome for the
prevention of CDI, AAD and the emergence of antibiotic-resistant
organisms. The Phase 2b proof-of-concept clinical trial is intended
to evaluate the effectiveness of ribaxamase to prevent the onset of
primary C. difficile infection (CDI), antibiotic-associated
diarrhea (AAD) and the emergence of antibiotic-resistant organisms
in patients hospitalized with a lower respiratory infection and
receiving IV ceftriaxone. A total of 412 subjects were randomized
in a 1:1 ratio receiving either 150 mg dose strength of SYN-004
(ribaxamase) or placebo orally QID from Day 1 and until 72 hours
following their last treatment of IV ceftriaxone. The sample size
was determined to provide 80% power to detect the treatment effect
with a one-sided alpha of 0.05. P-values were determined based on a
1-sided z-test for the comparison of the treatment difference as
pre-specified in the statistical analysis plan. To access the
ribaxamase mechanism of action video on Synthetic Biologics'
website, please click here.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a late-stage
clinical company developing therapeutics that 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,
antibiotic-associated diarrhea (AAD) and the emergence of
antibiotic-resistant organisms. 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 includes 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 potential of ribaxamase to
help address the serious health impacts associated with CDI and
infections from other opportunistic bacteria resulting from
dysbiosis of the gut microbiome, the industry data regarding the
expected incidence and economic burden of CDI, the potential
of ribaxamase to shorten hospital stays, diminish morbidity and
mortality and reduce the emergence of antibiotic resistant
organisms in the gut microbiome by protecting patients from primary
C. difficile infection resulting from IV antibiotic use, the
potential to reduce the economic burden to the healthcare system
from an effective therapeutic, the suggested trend toward a
reduction of incidence of antibiotic-associated diarrhea from all
causes, the expected timing of data release of exploratory
endpoints of the trial focused on the ability of ribaxamase to
prevent the emergence of antibiotic-resistant organisms in the gut
microbiome, the continued ongoing discussions with the FDA and CDC,
validation for our approach to advancing cutting edge microbiome
science, the continued preparation for the initiation of
pivotal Phase 2b/3 clinical trials for SYN-010, the potential of
the drug class to address serious diseases and public health
concerns, the ability of SYN-004 to protect the gut
microbiome from the effects of certain commonly used IV beta-lactam
antibiotics for the prevention of C. difficile
infection, antibiotic-associated diarrhea (AAD) and the emergence
of antibiotic-resistant organisms. 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 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 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.
1: Leffler DA et al. N Engl J Med 2015; 372: 1539-1548
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SOURCE Synthetic Biologics, Inc.