Synergy Pharmaceuticals Achieves Halfway Mark in Enrollment on Plecanatide Phase II/III Trial in Chronic Idiopathic Constipat...
09 Abril 2012 - 8:15AM
Synergy Pharmaceuticals, Inc. (Nasdaq:SGYP) (Nasdaq:SGYPU)
(Nasdaq:SGYPW), a developer of new drugs to treat gastrointestinal
disorders and diseases, today announced that it has successfully
achieved the halfway mark for total enrollment in its ongoing
plecanatide Phase II/III clinical trial in chronic idiopathic
constipation (CIC) patients. Over 800 patients have been screened
at present, resulting in a total of 440 randomized, enrolled
patients to date. The trial, designed to enroll 880 patients to
achieve 800 evaluable patients, was initiated on October 24, 2011.
The Company anticipates completing enrollment of the trial in the
third quarter of this year and reporting top line data in the
fourth quarter.
"We are pleased with the vigorous pace of enrollment in this
ongoing trial and the overall enthusiasm from the more than 100
clinical sites currently engaged in this clinical trial," said Gary
S. Jacob, Ph.D, President and Chief Executive Officer of Synergy
Pharmaceuticals.
The plecanatide CIC trial, entitled "A Randomized, 12-Week,
Double-Blind, Placebo-Controlled, Repeat-Dose, Oral, Dose-Ranging
Study to Assess the Safety and Efficacy of Plecanatide in Patients
with Chronic Idiopathic Constipation - Protocol SP304-20210,"
includes 3 doses of plecanatide (0.3, 1.0, 3.0 mg) plus a placebo
arm. Synergy developed a novel patient reported outcome (PRO)
questionnaire for CIC symptoms that is being validated in this
study. The primary endpoint is a responder analysis based on
improvement in the number of complete spontaneous bowel movements
in 9 of the 12 weeks of the treatment period. A nationwide
advertising campaign has been launched for this study, with
patients directed to the following website www.cicstudy.com or
to a call center (1-855-CIC-9200).
Synergy also plans to commence a plecanatide Phase II clinical
trial in constipation-predominant irritable bowel syndrome (IBS-C)
patients in the second half of 2012. The study is planned to be
conducted at 40 U.S. sites and to enroll over 300 patients. The
protocol is aligned with the FDA guidance on Clinical Evaluation of
Products for the Treatment of IBS-C issued in March, 2010. This
will be the first study of plecanatide in this patient
population.
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 CIC patients. In October, 2011, Synergy initiated
dosing of patients in a major Phase II/III clinical trial of
plecanatide to treat chronic idiopathic constipation. Plecanatide
is also being developed to treat IBS-C, with the first trial in
IBS-C patients planned for 2H2012. Synergy's second GC-C agonist
SP-333 is currently in pre-clinical development to treat
inflammatory bowel diseases. More information is available at
http://www.synergypharma.com.
About Plecanatide
Plecanatide is a member of a new class of essentially
non-systemic drugs, referred to as guanylate cyclase C (GC-C)
agonists, that are currently in development to treat CIC and IBS-C,
which includes a first-in-class drug being developed by Ironwood
and Forest Labs. Plecanatide is a synthetic analog of uroguanylin,
a natriuretic hormone that regulates ion and fluid transport in the
GI tract. Orally-administered plecanatide binds to and activates
GC-C receptors expressed on epithelial cells lining the GI mucosa,
resulting in activation of the cystic fibrosis transmembrane
conductance regulator (CFTR), and leading to augmented flow of
chloride and water into the lumen of the gut. Activation of the
GC-C receptor pathway is believed to facilitate bowel movement as
well as producing other beneficial physiological responses
including improvement in abdominal pain and inflammation. In animal
models, oral administration of plecanatide promotes intestinal
secretion and also ameliorates GI inflammation.
About Chronic Constipation (CC)
CC is a very common gastrointestinal disorder. Up to 34 million
Americans suffer from the disorder, and of this population about
8.5 million have a severe condition necessitating intervention. The
prevalence of the disorder is similar in other developed countries.
Patients with CC often experience hard stools, straining during
bowel movements and not enough bowel movements during the week.
People with chronic constipation can experience serious discomfort
which adversely affects their ability to work and their quality of
life.
About Irritable Bowel Syndrome (IBS)
Irritable bowel syndrome (IBS) is a condition marked by
disturbed bowel function and abdominal pain. IBS patients can have
three different sets of symptoms; diarrhea-predominant (IBS-D),
constipation-predominant (IBS-C) and mixed or alternating disorder
(IBS-M). The split in prevalence between the forms is about 1/3rd
each. In addition, most patients suffering from the mixed form of
IBS (IBS-M) are believed to mainly have constipation. An estimated
10 million people in the U.S. and an additional 10 million people
in the EU suffer from IBS-C. IBS (all forms) accounts for 12% of
adult visits to primary care physicians in the US.
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. Synergy does
not undertake any obligation to update or revise any
forward-looking statement. 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.
CONTACT: Investor Contact Information:
Danielle Spangler
The Trout Group
synergy@troutgroup.com
(646) 378-2924
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