ROCKVILLE, Md., Jan. 18, 2017 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a late-stage clinical company
developing therapeutics designed to preserve the microbiome to
protect and restore the health of patients, today confirmed plans
to initiate a Phase 2b/3 adaptive pivotal trial for SYN-010, the
Company's modified-release reformulation of lovastatin lactone
designed to reduce methane production by certain microorganisms
(M. smithii) in the gut to treat the underlying cause of
irritable bowel syndrome with constipation (IBS-C). The Company
anticipates initiating this trial by the end of the first quarter
of 2017.
In accordance with collaborative discussions with the FDA, key
components of the SYN-010 Phase 2b/3 adaptive pivotal trial will
include:
- A 12-week, multi-center, double-blind, placebo-controlled,
adaptive design clinical trial
- A study population of approximately 840 adult subjects
diagnosed with IBS-C
- Evaluation of efficacy and safety of two dose strengths of
SYN-010 (21 mg and 42 mg) compared to placebo
- Conducted in approximately 150 clinical sites in North America
- Study subjects will be randomized in a 1:1:1 ratio, receiving
either 21 mg of SYN-010, 42 mg of SYN-010, or placebo
- Enrollment is open to all IBS-C patients; breath-methane will
be measured at baseline to ensure a comparable ratio of high-to-low
breath methane IBS-C patients in each treatment arm
- An interim futility analysis may be conducted when
approximately 50% of patients in each dosing arm have completed
treatment
"We are pleased with the direction that we received from the FDA
on the clinical trial design for SYN-010," said Jeffrey Riley, President and Chief Executive
Officer. "With a clear path forward for SYN-010's clinical
development, we are one step closer to achieving our goal of
providing patients with a novel, potentially best-in-class therapy
that directly targets a cause of IBS-C, thereby alleviating
symptoms and preventing their recurrence."
Consistent with FDA written guidance, the primary objective for
this study is to determine the efficacy of SYN-010, measured as an
improvement from baseline in the percentage of overall weekly
responders[1] during the 12-week treatment period for SYN-010 21 mg
and 42 mg daily doses compared to placebo. Secondary efficacy
endpoints for both dose strengths of SYN-010 will measure changes
from baseline in abdominal pain, bloating, bowel movement frequency
and stool consistency. Exploratory outcomes include Adequate Relief
and quality of life measures using the well-validated EQ-5D-5L and
PAC-SYM patient questionnaires.
Synthetic Biologics also recently announced the achievement of
the primary endpoint from its Phase 2b proof-of-concept clinical
trial of SYN-004 (ribaxamase). Preliminary analysis of the data
demonstrated a statistically significant reduction in both C.
difficile infection (CDI) (p-value=0.045; relative risk
reduction of 71.4%) and new colonization by vancomycin-resistant
enterococci (VRE) (p-value=0.0002) for patients receiving
ribaxamase compared to placebo.
About Irritable Bowel Syndrome
IBS affects an estimated 10 to 15 percent of the population, or
as many as 45 million people in North
America. The illness affects both men and women; however,
two-thirds of diagnosed sufferers are women. It has been reported
that up to 20 percent of all IBS patients have IBS-C and current
FDA-approved therapies for the treatment of IBS-C, which include
prescription and over-the-counter laxatives, do little to treat the
underlying cause of the disease. These products provide patients
with temporary relief from the symptoms of constipation by
elevating the amount of water which passes through the
gastrointestinal tract, but tend to cause an IBS-C patient to swing
from suffering from constipation, to suffering from diarrhea.
About SYN-010
SYN-010 is a proprietary, modified-release formulation of
lovastatin lactone that is intended to reduce methane production by
certain microorganisms (M. smithii) in the gut while
minimizing disruption to the microbiome to treat an underlying
cause of IBS-C. SYN-010 is intended
to act primarily in the intestinal lumen while avoiding systemic
absorption, thereby targeting a major cause of IBS-C, not just the
symptoms. To access the SYN-010 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 designed to 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
(CDI), antibiotic-associated diarrhea (AAD) and the emergence of
antimicrobial-resistance (AMR). 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 plans to initiate a Phase 2b/3 adaptive pivotal
trial for SYN-010 towards the end of quarter 1 2017, the size of
the market, potential of SYN-010 to reduce methane
production for the treatment of IBS-C and to protect the
microbiome, and the size of the market 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 An overall 12-week responder is defined as a
subject with a weekly response in at least 50% of the weeks of
treatment (6 of 12 weeks). Weekly Responder is defined
as a patient who experiences a decrease in weekly average score for
worst abdominal pain in the past 24 hours of at least 30% compared
with Study 1 Baseline and a stool frequency increase of 1 or more
CSBM per week compared with Study 1 Baseline.
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SOURCE Synthetic Biologics, Inc.