ROCKVILLE, Md., Oct. 2, 2020 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE American: SYN), a diversified
clinical-stage company leveraging the microbiome to develop
therapeutics designed to prevent and treat gastrointestinal ("GI")
diseases in areas of high unmet need, today announced the
results of a planned interim futility analysis of the
investigator-sponsored Phase 2b
clinical study of SYN-010 being conducted by Cedars-Sinai Medical
Center ("CSMC"). Based on the review of the interim analysis, it
was concluded that although SYN-010 was well-tolerated, it is
unlikely to meet its primary objective by the time enrollment is
completed. As a result, CSMC has agreed to discontinue the trial
and will conduct a comprehensive review of the final data set and
publish its findings.
The Phase 2b study was being
conducted by the Medically Associated Science and Technology
("MAST") Program at CSMC and designed to evaluate two dose
strengths of oral SYN-010 (21 mg and 42 mg) in patients diagnosed
with irritable bowel syndrome with constipation (IBS-C). The
primary objective of the study was intended to determine the
efficacy of SYN-010, measured as an improvement from baseline in
the weekly average number of complete spontaneous bowel movements
("CSBMs") during the 12-week treatment period for SYN-010 21 mg and
42 mg daily doses relative to placebo.
"We are grateful to the patients and Cedars-Sinai who supported
this clinical trial. Although the results were disappointing for
SYN-010, we remain committed to the development of new life
changing medications for GI diseases" said Steven A. Shallcross, Chief Executive Officer of
Synthetic Biologics. "Looking forward, we remain focused on working
with our clinical development partners to advance the planned Phase
1b/2a clinical trial of SYN-004
(ribaxamase) in allogeneic hematopoietic cell transplant (HCT)
patients, and to advance the clinical development program for
SYN-020 intestinal alkaline phosphatase (IAP) in multiple potential
indications."
The patent rights covering the use of SYN-010 are owned by
Cedars-Sinai Medical Center and are exclusively licensed by
Cedars-Sinai Medical Center to Synthetic Biologics.
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 condition 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 they 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 learn
more about SYN-010's unique mechanism of action, please click
here.
About Synthetic Biologics, Inc.
Synthetic Biologics,
Inc. (NYSE American: SYN) is a clinical-stage company leveraging
the microbiome to develop therapeutics designed to prevent and
treat gastrointestinal (GI) diseases in areas of high unmet need.
The Company's lead clinical candidates are: (1) SYN-004
(ribaxamase) which is designed to degrade certain commonly used
intravenous (IV) beta-lactam antibiotics within the
gastrointestinal (GI) tract to prevent microbiome damage, C.
difficile infection (CDI), overgrowth of pathogenic organisms,
the emergence of antimicrobial resistance (AMR) and acute
graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell
transplant (HCT) recipients, and (2) 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). The Company is also advancing SYN-020,
an oral formulation of the enzyme intestinal alkaline phosphatase
(IAP) to treat both local GI and systemic diseases. 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 working with clinical development partners to advance the
planned Phase 1b/2a clinical trial of
SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant
(HCT) patients, and to advance the clinical development program for
SYN-020 intestinal alkaline phosphatase (IAP) in multiple potential
indications. 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, a failure of additional pre-clinical studies
of SYN-020 to achieve similar results to those previously achieved
or to provide support for exercise of the option, a failure to
receive the necessary regulatory approvals for commercialization of
Synthetic Biologics' therapeutics, a failure of Synthetic
Biologics' clinical trials, and those conducted by investigators,
for SYN-004, SYN-010 and SYN-020 to be commenced or completed on
time or to achieve desired results and benefits, especially in
light of COVID-19, a failure of Synthetic Biologics' clinical
trials to continue enrollment as expected or receive anticipated
funding, a failure of Synthetic Biologics to successfully develop,
market or sell its products, Synthetic Biologics' inability to
maintain its material licensing agreements, or a failure by
Synthetic Biologics or its strategic partners to successfully
commercialize products and other factors described in Synthetic
Biologics' Annual Report on Form 10-K for the year ended
December 31, 2019 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.