Synergy Pharmaceuticals Announces New Plecanatide Data Presentations at Upcoming Scientific Meeting & Provides Update on IBS-...
September 28 2016 - 9:30AM
Business Wire
Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced that
the company will present new data on plecanatide, an
investigational compound for the treatment of chronic idiopathic
constipation (CIC) and irritable bowel syndrome with constipation
(IBS-C), at the American College of Gastroenterology (ACG) annual
scientific meeting at The Venetian in Las Vegas, October 14-19,
2016.
The following two posters will be presented in Hall C on Monday,
October 17th from 10:30 a.m.-4:00 p.m. PT with author presentation
at the poster from 1:00-2:15 p.m. PT:
- P1041A. Efficacy and Safety of
Plecanatide in the Treatment of Chronic Idiopathic Constipation
(CIC): Pooled Results from Two Phase 3 Studies*2016 ACG Presidential Poster Award
-- Presenter: Satish S.C. Rao, MD, PhD,
Professor of Medicine, Division Chief Fellowship Program Director,
Director Digestive Health Center
- P1120. Safety and Tolerability of
Plecanatide in Patients with Chronic Idiopathic Constipation:
Long-term Evidence from an Open-Label Study
-- Presenter: Marianela De La Portilla, MD,
Genome Research Group, Miami, FL
Plecanatide is a once-daily, orally-administered compound
currently being evaluated by the U.S. Food and Drug Administration
(FDA) for the treatment of CIC and the Prescription Drug User Fee
Act (PDUFA) target action date for plecanatide is January 29,
2017.
In addition, Synergy has already completed patient recruitment
for the two double-blind placebo-controlled phase 3 clinical trials
with plecanatide in IBS-C and remains on-track to report top-line
data from both trials in the fourth quarter of this year. Pending
approval in the CIC indication, Synergy plans to file a New Drug
Application Supplement with Clinical Data (sNDA) for plecanatide in
IBS-C in the first quarter of 2017 and expects a 10-month review
period from submission.
About Chronic Idiopathic Constipation (CIC)
CIC affects 14 percent of the population in North America,
disproportionately affecting women and older adults. People with
CIC have persistent symptoms of difficult and infrequent bowel
movements. CIC can severely impact people’s daily lives, increasing
stress levels and anxiety.
About Plecanatide
Plecanatide is a peptide made up of 16 amino acids and, with the
exception of a single amino acid substitution, it is identical to
uroguanylin. Plecanatide is the first investigational drug designed
to replicate the function of uroguanylin, a naturally occurring and
endogenous human GI peptide which acts in a pH-dependent manner
targeting GC-C receptors primarily in the proximal small intestine.
Plecanatide stimulates fluid secretion and promotes stool
consistency necessary to support normal bowel function.
About Synergy Pharmaceuticals
Synergy is a biopharmaceutical company focused on the
development and commercialization of novel GI therapies. The
company has pioneered discovery, research and development efforts
around uroguanylin analogs for the treatment of functional GI
disorders and inflammatory bowel disease. Synergy’s proprietary
uroguanylin analog technology platform includes two lead product
candidates – plecanatide and dolcanatide. For more information,
please visit www.synergypharma.com.
Forward-Looking Statement
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, 2015 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160928005239/en/
Company:Synergy Pharmaceuticals Inc.Gem Hopkins,
212-584-7610VP, Investor Relations and Corporate
Communicationsghopkins@synergypharma.com
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