Full Press Release Details
Synthetic Biologics Provides Update on
Investigator-Sponsored Phase 2b Clinical Study
of SYN-010 in IBS-C Patients
MD, October 2, 2020 - 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.
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
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.
For further information, please contact:
Synthetic Biologics, Inc. (Corporate and
Vincent I. Perrone, Director Corporate Communication, (240)
660-2000, info@syntheticbiologics.com
Gregory Kelley, Senior Vice President, (404) 836-2302, gregory.kelley@ogilvy.com