Synergy Pharmaceuticals Begins Phase IIb Trial of Plecanatide in Irritable
Bowel Syndrome With Constipation (IBS-C)
NEW YORK, Dec. 27, 2012 (GLOBE NEWSWIRE) -- Synergy Pharmaceuticals, Inc.
(Nasdaq:SGYP), a developer of new drugs to treat gastrointestinal (GI)
disorders and diseases, announced today that dosing has commenced in a Phase
IIb clinical trial of plecanatide to treat patients with
constipation-predominant irritable bowel syndrome (IBS-C).
This trial is being conducted at 70 sites in the United States and includes
350 patients with IBS-C who will be treated with one of four doses of
plecanatide (0.3, 1.0, 3.0, or 9.0 mg) or placebo, taken once daily over a
period of 12 weeks. PAREXEL International is the Contract Research
Organization for the trial.
"We are pleased to be developing plecanatide for the treatment of IBS-C, a
functional GI disorder of significant burden to patients," said Gary S. Jacob,
Ph.D., President and Chief Executive Officer of Synergy. "Synergy is about to
complete an independent study of plecanatide in patients with chronic
idiopathic constipation, and will be releasing top-line data from this trial
early in January, 2013. We believe that plecanatide, which is an analog of the
natural GI hormone uroguanylin, has the potential to produce an ideal
combination of efficacy and safety for patients with IBS-C."
Clinical Trial Design
Patients must meet the Rome III criteria for IBS as demonstrated by a history
of recurrent abdominal pain or discomfort covering at least 3 days/month in
the last 3 months associated with two or more of: 1) improvement with
defecation, 2) onset associated with a change in frequency of stool, and 3)
onset associated with a change in form (appearance) of stool. Patients must
also meet the criteria for the IBS-C subtype, which is further characterized
by stool pattern such that ≥ 25% of defecations are hard or lumpy stools and ≤
25% of defecations are loose or watery stools.
The trial will measure the mean change in complete spontaneous bowel movements
(CSBM's) over the 12-week treatment period relative to patient's baseline
weekly CSBM rate established during the screening phase of the study. The
trial will also evaluate spontaneous bowel movements (SBM's) and daily
abdominal pain, discomfort and bloating scores as well as the impact of
plecanatide on disease-specific quality of life measures. For further
information on the trial, please visit www.cibsstudy.com or the
Plecanatide is a member of a new class of essentially non-systemic drugs,
referred to as guanylate cyclase C (GC-C) agonists, that is currently in
development to treat CIC and IBS-C. 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
movements 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 Irritable Bowel Syndrome with Constipation (IBS-C)
Approximately 20 percent of the U.S. adult population, or one in five
Americans, have symptoms of IBS, making it one of the most common disorders
diagnosed by doctors. It occurs more often in women than in men (2-3:1 ratio),
and it begins before the age of 35 in about 50 percent of people.
Irritable Bowel Syndrome (IBS) is characterized by recurrent episodes of
abdominal pain and discomfort with associated alterations in bowel habits.
Abdominal discomfort or pain is a universal feature required for the diagnosis
of IBS and the predominant abnormal bowel pattern experienced by the patient
leads to the subtyping of IBS as: diarrhea-predominant (D-IBS),
constipation-predominant (C-IBS), or mixed IBS (M-IBS).Only IBS-C patients,
are targeted for treatment with plecanatide.
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
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.
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