Synergy Pharmaceuticals Reaches Halfway Mark for Second Pivotal Phase 3 Trial of Plecanatide in Patients with Chronic Idiopat...
September 18 2014 - 6:00AM
Business Wire
Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced that
it has reached the halfway mark for total enrollment in the second
pivotal phase 3 trial of plecanatide in patients with chronic
idiopathic constipation (CIC).
The trial is currently being conducted at 180 sites and has
randomized over 675 CIC patients. This is the second of two ongoing
phase 3 pivotal trials designed to confirm the efficacy and safety
of both 3.0 mg and 6.0 mg plecanatide once-daily oral tablet versus
placebo in patients with CIC. Synergy announced it had achieved the
halfway mark for total enrollment in the first phase 3 CIC trial in
July 2014. The Company plans to release top-line data from the
first phase 3 CIC trial in the second quarter of 2015 and top-line
data from the second study in the third quarter of 2015.
For more information on the two plecanatide pivotal phase 3 CIC
trials, please visit
http://clinicaltrials.gov/ct2/show/NCT01982240?term=plecanatide&rank=1
or
http://clinicaltrials.gov/ct2/show/NCT02122471?term=plecanatide&rank=2
About Plecanatide
Plecanatide is Synergy’s lead uroguanylin analog in late-stage
clinical development to treat patients with CIC and irritable bowel
syndrome with constipation (IBS-C). Uroguanylin is a natural
gastrointestinal (GI) hormone produced by humans in the small
intestine and plays a key role in regulating the normal functioning
of the digestive tract through its activity on the guanylate
cyclase-C (GC-C) receptor. The GC-C receptor is known to be a
primary source for stimulating a variety of beneficial
physiological responses. Orally administered plecanatide mimics
uroguanylin's functions by binding to and activating the GC-C
receptor to stimulate fluid and ion transit required for normal
bowel function. Synergy has successfully completed a phase 2b trial
of plecanatide in 951 patients with CIC and is currently enrolling
patients in two pivotal phase 3 CIC trials. The company also
recently announced positive top-line data results from a phase 2b
dose-ranging study with plecanatide in patients with IBS-C. Synergy
plans to initiate the pivotal phase 3 IBS-C program in the fourth
quarter of 2014.
About Synergy Pharmaceuticals
Synergy Pharmaceuticals (NASDAQ: SGYP) is a biopharmaceutical
company focused on the development of novel therapies based on the
natural human hormone, uroguanylin, to treat GI diseases and
disorders. Synergy has created two unique analogs of uroguanylin –
plecanatide and SP-333 – designed to mimic the natural hormone’s
activity on the GC-C receptor and target a variety of GI
conditions. SP-333 is currently in phase 2 development for
opioid-induced constipation and is also being explored for
ulcerative colitis. For more information, please visit
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, 2013 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.
Synergy Pharmaceuticals Inc.Gem Gokmen,
212-584-7610ggokmen@synergypharma.com
Synergy Pharmaceuticals, Inc. (NASDAQ:SGYP)
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