Synergy Pharmaceuticals Completes Phase I Trial of SP-333, a Second-Generation
GC-C Agonist to Treat Gastrointestinal Diseases
NEW YORK, Dec. 28, 2012 (GLOBE NEWSWIRE) -- Synergy Pharmaceuticals Inc.
(Nasdaq:SGYP), a developer of new drugs to treat gastrointestinal (GI)
disorders and diseases, announced today the successful completion of a Phase I
single-ascending-dose clinical trial of SP-333, a guanylate cyclase C (GC-C)
agonist designed to treat ulcerative colitis (UC) and other GI diseases.
SP-333 has exhibited potent anti-inflammatory activity in animal studies of
colitis, displaying a novel mechanism-of-action that the Company believes can
provide a new way to treat UC patients with mild to moderate disease.
This study was designed as a placebo-controlled, dose-escalating, single-dose
trial in healthy adult volunteers, primarily focused on exploring the safety
profile of SP-333.Eight cohorts were dosed, ranging from 0.1 to 60 mg of
SP-333.There were no serious or unexpected adverse events in this
study.Importantly, SP-333 exhibited gastrointestinal pharmacodynamic
characteristics that were anticipated based on its GC-C receptor agonist
activity. A multi-dose, dose-escalation trial in volunteers is planned to
start in January.
"We specifically designed SP-333 to have superior stability against
proteolytic degradation which normally occurs in intestinal fluid designed to
break down proteins and peptides as part of the normal digestive process,"
said Dr. Kunwar Shailubhai, Chief Scientific Officer of Synergy
Pharmaceuticals."SP-333, to our knowledge, represents the most
proteolytically stable analog of uroguanylin - the physiological agonist of
GC-C - ever developed, and is designed to remain biologically active in the
gut, a factor we consider ideal for its potential use in treating UC."
SP-333 is a synthetic analog of uroguanylin, a natriuretic peptide hormone
which is normally produced in the lumen of the intestinal tract. Deficiency of
uroguanylin is likely to be one of the primary reasons associated with
formation of polyps as well as debilitating and difficult-to-treat GI
inflammatory disorders such as ulcerative colitis and Crohn's disease.
Orally-administered SP-333 binds to and activates the GC-C receptor expressed
on epithelial cells lining the GI mucosa, resulting in stimulation of cyclic
GMP in target tissues. SP-333 has been found to be highly stable against
proteolysis in simulated intestinal fluid for up to 24 hours. Its enhanced
stability makes this peptide an extremely potent GC-C agonist in animal
studies in mice and monkeys, promoting bowel movement in monkeys, and
ameliorating GI inflammation in mice, respectively.SP-333 has been found to
exhibit potent anti-inflammatory activity in several animal models of
experimental colitis, through a mechanism-of-action involving inhibition of
NF-kB to suppress production of pro-inflammatory cytokines.
About Ulcerative Colitis
More than 500,000 Americans are afflicted with ulcerative colitis (UC), a type
of Inflammatory Bowel Disease (IBD) that causes chronic inflammation of the
colon.Along with Crohn's disease, the other major form of IBD, ulcerative
colitis is painful and debilitating. Patients with UC are at increased risk
for colon cancer and may ultimately require surgical removal of the colon.
There is currently no medical cure for ulcerative colitis. Long-term
remission with current treatments is limited. Therefore, there is a need for
new treatment approaches to treat patients with ulcerative colitis.
About Synergy Pharmaceuticals Inc.
Synergy is a biopharmaceutical company focused on the development of new drugs
to treat gastrointestinal disorders and diseases. Synergy's lead proprietary
drug candidate plecanatide is a synthetic analog of the human gastrointestinal
(GI) hormone uroguanylin, and functions by activating the guanylate cyclase C
receptor on epithelial cells of the GI tract. Synergy completed a Phase I
study of plecanatide in healthy volunteers, a Phase IIa clinical trial in
chronic idiopathic constipation (CIC) patients and has just completed a major
Phase II/III clinical trial of plecanatide to treat CIC. Top-line results are
expected to be released the first week of January 2013.Synergy intends to
have an end of Phase II CIC meeting with the FDA in the first half of
2013.Synergy's second GC-C agonist, SP-333, is currently in a Phase I
clinical trial in volunteers.The development program for SP-333 is for
treatment of inflammatory bowel diseases. More information is available at
Certain statements in this press release are forward-looking within the
meaning of the Private Securities Litigation Reform Act of 1995. These
statements may be identified by the use of forward-looking words such as
"anticipate," "planned," "believe," "forecast,""estimated," "expected," and
"intend," among others. These forward-looking statements are based on
Synergy's current expectations and actual results could differ materially.
There are a number of factors that could cause actual events to differ
materially from those indicated by such forward-looking statements. These
factors include, but are not limited to, substantial competition; our ability
to continue as a going concern; our need for additional financing;
uncertainties of patent protection and litigation; uncertainties of government
or third party payer reimbursement; limited sales and marketing efforts and
dependence upon third parties; and risks related to failure to obtain FDA
clearances or approvals and noncompliance with FDA regulations. As with any
pharmaceutical under development, there are significant risks in the
development, regulatory approval and commercialization of new products. There
are no guarantees that future clinical trials discussed in this press release
will be completed or successful or that any product will receive regulatory
approval for any indication or prove to be commercially successful. Investors
should read the risk factors set forth in Synergy's Form 10-K for the year
ended December 31, 2011 and other periodic reports filed with the Securities
and Exchange Commission.While the list of factors presented here is
considered representative, no such list should be considered to be a complete
statement of all potential risks and uncertainties. Unlisted factors may
present significant additional obstacles to the realization of forward-looking
statements. Forward-looking statements included herein are made as of the date
hereof, and Synergy does not undertake any obligation to update publicly such
statements to reflect subsequent events or circumstances.
CONTACT: Media Contact
The Trout Group
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