DGAP-News: Synergy Pharmaceuticals Presents Poster on Novel Mechanism of Action of SP-333, an Agonist of Guanylate Cyclase-C for Treatment of Ulcerative Colitis
(firmenpresse) - Synergy Pharmaceuticals
14.12.2012 14:00
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Scientific Poster Presentation at 2012 Advances in IBD Conference
NEW YORK, 2012-12-14 14:00 CET (GLOBE NEWSWIRE) --
Synergy Pharmaceuticals Inc. (Nasdaq:SGYP), a developer of new drugs to treat
gastrointestinal disorders and diseases, today announced that a poster
presentation on SP-333, Synergy's next-generation guanylate cyclase-C (GC-C)
agonist to treat ulcerative colitis, will be made at the 2012 Advances in
Inflammatory Bowel Diseases, Crohn's&Colitis Foundation's Clinical&Research
Conference. The conference takes place December 13-15 at the Westin Diplomat in
Hollywood, FL.
The poster describes animal studies showing that oral treatment with SP-333, an
analog of uroguanylin, ameliorated gastrointestinal (GI) inflammation in
dextran sodium sulfate (DSS) induced colitis in mice, and that down-regulation
of NF-kB and pro-inflammatory cytokines was associated with SP-333
administration. The data also demonstrate that systemic absorption of orally
administered SP-333 is minimal, and is unaffected by the severity of the
experimental colitis. Synergy recently completed a single-dose, dose-escalating
Phase I trial of SP-333 in healthy adult volunteers, and is planning to
initiate a multi-dose, dose-escalation study in healthy volunteers in early
2013.
Recent studies suggest that expression of uroguanylin, the native GC-C agonist
expressed in the human GI tract, is down-regulated in inflamed tissue from
patients with Crohn's disease and in patients with ulcerative colitis, implying
that uroguanylin deficiency may be associated with disruption of intestinal
barrier function, one of the primary hypothesized causes of the pathogenesis of
inflammatory bowel disease.
'Oral treatment with SP-333 to augment intestinal GC-C activation may represent
a novel approach for restoring mucosal barrier function and suppressing
inflammation,' said Dr. Kunwar Shailubhai, Chief Scientific Officer of Synergy
Pharmaceuticals, Inc. 'In experimental models of colitis in mice, treatment
with SP-333 ameliorates GI inflammation possibly through inhibition of NF-kappa
B signaling to suppress production of pro-inflammatory cytokines.'
The poster: SP-333, a Guanylate Cyclase-C Agonist, Ameliorates DSS-colitis in
Mice via a Novel Cyclic GMP-Mediated Mechanism (P-198), authored by Kunwar
Shailubhai, John Foss, Graham Zhang, Krishna P Arjunan, Rong Feng, Stephen
Comiskey, Gary S. Jacob, and Scott E. Plevy, will be presented by Dr.
Shailubhai on Friday December 14 between 6 PM and 7PM at the Westin Diplomat in
Hollywood, FL.
About SP-333
SP-333 is a synthetic analog of uroguanylin, a natriuretic hormone which is
normally produced in the body's 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 guanylate cyclase C (GC-C) expressed on epithelial cells lining the
GI mucosa, resulting in stimulation of cyclic GMP in target tissues. 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.
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
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 and a Phase IIa clinical trial in chronic
idiopathic constipation (CIC) patients. In August of 2012, Synergy completed
enrollment of patients in a major Phase II/III clinical trial of plecanatide to
treat CIC. Plecanatide is also being developed to treat irritable bowel
syndrome with constipation (IBS-C), with the first trial in IBS-C patients
initiated in the second half of 2012. Synergy's second GC-C agonist SP-333 is
in clinical development to treat inflammatory bowel diseases, and is presently
in a Phase I trial in healthy volunteers. 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(at)earthlink.net
Investor Contact:
Danielle Spangler
The Trout Group
synergy(at)troutgroup.com
(646) 378-2924
News Source: NASDAQ OMX
14.12.2012 Dissemination of a Corporate News, transmitted by DGAP -
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Language: English
Company: Synergy Pharmaceuticals
United States
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ISIN: US8716393082
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End of Announcement DGAP News-Service
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333
an-agonist-of-guanylate-cyclase
c-for-treatment-of-ulcerative-colitis
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Datum: 14.12.2012 - 14:00 Uhr
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