Synergy Pharmaceuticals
28.12.2012 11:00
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NEW YORK, 2012-12-28 11:00 CET (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.'
About SP-333
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
http://www.synergypharma.com.
Forward-Looking Statements
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
Janet Skidmore
Office: 215-658-4915
Mobile: 215-429-2917
skidmorecomm@earthlink.net
Investor Contact
Danielle Spangler
The Trout Group
synergy@troutgroup.com
(646) 378-2924
News Source: NASDAQ OMX
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Language: English
Company: Synergy Pharmaceuticals
United States
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ISIN: US8716393082
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DGAP-News: Synergy Pharmaceuticals Completes Phase I Trial of SP-333, a Second-Generation GC-C Agonist to Treat Gastrointestinal Diseases
| Source: EQS Group AG