ROCKVILLE, Md., Feb. 2, 2016 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a clinical stage company focused
on developing therapeutics to protect the gut microbiome, today
reported independent third party analysis of the
investigator-sponsored Phase 2 clinical trial that evaluated
Trimesta as a treatment for relapsing-remitting multiple sclerosis
(RRMS) in women (NCT00451204).
In November 2015, Synthetic
Biologics disclosed its intention to conduct independent third
party analysis of the Phase 2 RRMS clinical trial data for purposes
of evaluating Trimesta's potential further development. Evaluations
were conducted by two independent clinical research organizations.
Both the clinical and magnetic resonance imaging (MRI) results from
the independent analyses did not demonstrate statistically
significant differences between the Trimesta plus Copaxone
treatment group compared to the Copaxone plus placebo group at
either 12 or 24 months. On the basis of these findings, the Company
has decided to terminate its license and clinical trial agreements
relating to Trimesta with the Regents of the University of California.
Third Party Analysis of Trimesta Data from
Investigator-Sponsored Phase 2 RRMS Clinical Trial
(differences between the Trimesta plus Copaxone treatment group
compared to the Copaxone plus placebo group):
Clinical Analysis:
- Annualized relapse rate at 24 months 0.17 vs. 0.25
(p=0.302)
- Annualized relapse rate at 12 months 0.13 vs. 0.19
(p=0.252)
MRI Analysis:
- Brain Volumes – change from baseline in patients without
enhancing lesions at baseline
- Whole brain at 12 months -0.34 vs. -0.48 (p=0.321) and 24
months -0.70 vs. -0.79 (p=0.686)
- Whole gray matter at 12 months -0.44 vs. -0.70 (p=0.130) and 24
months -0.92 vs. -0.98 (p=0.772)
- Cortical gray matter at 12 months -0.36 vs. -0.76 (p=0.071) and
24 months -0.93 vs. -1.12 (p=0.487)
- White matter at 12 months -0.18 vs. -0.15 (p=0.879) and 24
months -0.38 vs. -0.48 (p=0.713)
- Enhancing lesion volume – odds ratio (OR) for treatment effect
- OR 1.35 at 12 months (p=0.46)
- OR 1.39 at 24 months (p=0.43)
- Total T2 lesion volume – change from baseline
- 29% vs. 27% at 12 months (p=0.54)
- 25% vs. 23% at 24 months (p=0.67)
"We are disappointed with the outcome of the data analyses which
did not demonstrate statistically significant treatment effects in
this study," said Jeffrey Riley,
Chief Executive Officer of Synthetic Biologics. "We intend to focus
the Company's resources on its other programs, including our two
Phase 2 gut microbiome programs which have both demonstrated
positive topline clinical results."
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical stage
company developing therapeutics to protect the microbiome while
targeting pathogen-specific diseases. The Company's lead candidates
in Phase 2 development include: (1) SYN-004 which is designed to
protect the gut microbiome from the effects of certain commonly
used intravenous (IV) antibiotics for the prevention of C.
difficile infection and antibiotic-associated diarrhea (AAD), 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). In
collaboration with Intrexon Corporation (NYSE: XON), the Company is
developing a preclinical stage monoclonal antibody for the
prevention and treatment of Pertussis, and discovery stage
biotherapeutics for the treatment of phenylketonuria (PKU). For
more information, please visit Synthetic Biologics' website at
www.syntheticbiologics.com.
This press 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 Synthetic Biologics' intention to focus its resources
on its other programs including its two Phase 2
gut microbiome programs and the future clinical outcomes of those
product candidates. These forward-looking statements are
based on management's expectations and assumptions as of the date
of this press release and 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
current expectations include, among others, 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,
to be commenced or completed on time or to achieve desired results,
a failure of Synthetic Biologics' clinical trials to receive
anticipated funding, a failure of Synthetic Biologics to
successfully develop, market or sell its products, Synthetic
Biologics' inability to maintain material licensing agreements, or
a failure by Synthetic Biologics or its strategic partners to
successfully commercialize products and other risks and
uncertainties described in Synthetic Biologics' Annual Report on
Form 10-K for the year ended December 31,
2014 and its other filings with the SEC, including
subsequent periodic reports on Forms 10-Q and 8-K. The information
in this press release is provided only as of the date of this press
release, and Synthetic Biologics undertakes no obligation to revise
or update any forward-looking statements contained in this press
release, except as required by law.
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SOURCE Synthetic Biologics, Inc.