Synergy Pharmaceuticals
21.05.2013 16:01
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NEW YORK, 2013-05-21 16:00 CEST (GLOBE NEWSWIRE) --
Synergy Pharmaceuticals Inc. (Nasdaq:SGYP), a developer of new drugs to treat
patients with gastrointestinal disorders and diseases, today presented positive
safety and efficacy results from its large multicenter trial of plecanatide in
patients with chronic idiopathic constipation (CIC) at Digestive Disease Week
(DDW) in Orlando, FL.
The data were presented at the Late-Breaking Abstract Session of the American
Gastroenterological Association (AGA) by lead author Dr. Philip B. Miner,
President and Medical Director of the Oklahoma Foundation for Digestive
Research.
Plecanatide, Synergy's investigational drug for the treatment of CIC and
irritable bowel syndrome with constipation (IBS-C), is a guanylate cyclase-C
(GC-C) agonist. This novel drug mimics the function of the natural human
peptide hormone, uroguanylin.
The clinical trial was designed to evaluate whether plecanatide could increase
the number of complete spontaneous bowel movements (CSBMs), as well as benefit
other bowel measures associated with the constipated state such as stool
consistency and straining, along with general quality of life, in people with
CIC. In the study, 951 patients with CIC were randomized to four study arms to
determine the efficacy and safety of three oral doses of plecanatide (0.3, 1.0,
or 3.0 mg, daily), compared to placebo, over the course of a 12-week dosing
regimen.
'All three doses of plecanatide demonstrated statistically significant
improvement in the number of complete, spontaneous bowel movements experienced
by study participants who responded to treatment,' said Dr. Miner. 'In addition
to increased frequency of CSBMs, participants reported improvements in other
symptoms of chronic constipation, including decreased stool hardness and
straining. All doses of plecanatide appeared to be safe and well tolerated, and
safety data were consistent with Synergy's previous Phase I and IIa trials of
plecanatide.'
'We are very pleased to share these compelling new data at DDW supporting the
efficacy and safety of plecanatide as a potential new treatment for patients
suffering with CIC,' said Dr. Gary S. Jacob, President and CEO of Synergy. 'We
are moving full-speed ahead with development of plecanatide to treat CIC, and
plan to initiate pivotal trials in the second half of 2013. In addition, we
presently have a Phase 2b trial of plecanatide in IBS-C patients underway and
expect to release top-line data in 1Q2014.'
Key clinical findings presented at DDW:
Efficacy
Increasing efficacy was observed at increasing dose levels of plecanatide. The
greatest improvement in CSBM was observed at the 3 mg plecanatide dose. Other
efficacy results include:
-- Over the course of the 12-week study, 19% of participants treated daily
with 3 mg plecanatide were durable* responders (vs. 10.7% for placebo;
p<0.01).
-- More than half of patients dosed at 3 mg plecanatide treatment experienced
an increase of at least one CSBM per week relative to baseline (52.3% vs.
36.8% for placebo; p<0.001).
-- Participants achieved their first spontaneous bowel movement after
ingestion of 3 mg plecanatide in less than half the time of those taking
placebo (median time of 12.5 hours plecanatide vs. 27.3 for placebo;
p<0.001).
-- Statistically significant improvements in other key secondary endpoints
were also observed, including stool consistency and straining (3 mg
plecanatide vs. placebo; p<0.001).
-- Responders to treatment reported statistically significant improvements in
constipation-associated symptoms and quality of life relative to baseline
(3 mg plecanatide vs. placebo; p<0.001).
Safety
In this large multicenter trial, all doses of plecanatide studied appeared to
be safe and well tolerated. There were no serious adverse events attributed to
study treatment. The most common adverse event reported was diarrhea (9.7% at 3
mg plecanatide vs. 1.3% placebo). Notably, study withdrawal due to diarrhea was
infrequent (3% at 3 mg plecanatide vs. 0.4% for placebo). All but one case of
diarrhea was mild or moderate in severity.
Late-Breaking Abstract Session Citation
Abstract # 925g: Plecanatide, a Novel Guanylate-Cyclase C (GC-C) Receptor
Agonist, is Efficacious and Safe in Patients with Chronic Idiopathic
Constipation (CIC): Results from a 951 Patient, 12 Week, Multi-Center Trial.
Miner, Philip B.1; Surowitz, Ron2; Fogel, Ron3; Koltun, William4; Drossman,
Douglas A.5; Camilleri, Michael6; Mangel, Allen7; Barrow, Laura8; Jacob, Gary
S.8; Shailubhai, Kunwar8.
1Oklahoma Foundation for Digestive Research, Oklahoma City, OK. 2Health
Awareness Inc., Jupiter, FL. 3Clinical Research Institute of Michigan,
Chesterfield, MI. 4Medical Center for Clinical Research, San Diego, CA. 5School
of Medicine, University of North Carolina, Chapel Hill, NC. 6Mayo Clinic,
Rochester, MN. 7RTI, Research Triangle Park, NC. 8Synergy Pharmaceuticals, New
York, NY.
(ClinicalTrials.gov Identifier: NCT01429987)
*Durable responder is defined as: a responder in at least 9 of 12 weeks of
study, and a responder in at least 3 of the last 4 weeks of treatment.
About Digestive Disease Week
Digestive Disease Week(r) (DDW(r)) is the largest international gathering of
physicians, researchers and academics in the fields of gastroenterology,
hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the
American Association for the Study of Liver Diseases (AASLD), the American
Gastroenterological Association (AGA) Institute, the American Society for
Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary
Tract (SSAT), DDW takes place May 18 - 21, 2013, at the Orange County
Convention Center, FL. The meeting showcases more than 5,000 abstracts and
hundreds of lectures on the latest advances in GI research, medicine and
technology. More information can be found at www.ddw.org.
About Synergy Pharmaceuticals Inc.
Synergy is a biopharmaceutical company focused on the development of new drugs
to treat patients with gastrointestinal disorders and diseases. Synergy's lead
proprietary drug candidate, plecanatide, is a synthetic analog of the natural
human peptide hormone, uroguanylin, and functions by activating the guanylate
cyclase-C (GC-C) receptor on epithelial cells of the GI tract. Synergy
completed positive Phase I and Phase II clinical trials in patients with
chronic idiopathic constipation (CIC). Detailed positive findings from its
large multicenter trial of plecanatide in patients with CIC are being presented
at Digestive Disease Week (DDW) in Orlando, FL and will be published this year.
Synergy is also developing plecanatide for the treatment of irritable bowel
syndrome with constipation (IBS-C), having initiated the first trial in IBS-C
patients in late 2012. Synergy's second GC-C agonist, SP-333, is in clinical
development for the treatment of ulcerative colitis (UC). The first Phase I
trial in healthy volunteers was recently completed. More information is
available at http://www.synergypharma.com
About Chronic Constipation
Chronic constipation is the most common digestive complaint in the United
States and the world. About 15%, or 45 million people, suffer from chronic
constipation in the U.S., with a similar prevalence in other developed
countries. Although chronic constipation affects both men and women of every
age, it disproportionately impacts women as well as the elderly, a large and
growing population.
Current treatments provide temporary relief, but because they fail to address
the underlying causes of chronic constipation, they do not normalize patients'
bowel function. Such treatments are also associated with unpleasant side
effects, the most common of which is diarrhea, causing patients to see-saw
between extremes. As a result, most doctors and their patients are dissatisfied
with current treatments for chronic constipation.
Chronic constipation is also a significant driver of healthcare costs.
Healthcare systems are spending millions of dollars annually to diagnose and
treat this disorder, including $820 million annually on over-the-counter
laxatives in the U.S. alone.
About Plecanatide
Plecanatide is a promising investigational drug being developed by Synergy
Pharmaceuticals for the treatment of chronic idiopathic constipation (CIC) and
irritable bowel syndrome with constipation (IBS-C). Plecanatide is a member of
a new class of essentially non-systemic oral drugs, known as guanylate
cyclase-C (GC-C) agonists. GC-C agonists act by targeting GC-C receptors in the
gut. By acting locally in the proximal intestine, plecanatide promotes
intestinal fluid secretion needed for normal bowel function and reduces the
abdominal symptoms that are often associated with GI disorders. Plecanatide is
a synthetic analog of uroguanylin, a natural human peptide hormone that
regulates ion and fluid transport in the GI tract.Uroguanylin binds to and
activates GC-C receptors on mucosal epithelial cells lining the GI tract.
Activation of these receptors triggers an increase in a key intracellular
mediator called cyclic guanosine monophosphate (cGMP) which induces fluid
secretion into the intestinal lumen necessary for normal bowel movements.
Increased cGMP has also been demonstrated to produce other physiologic benefits
related to abdominal discomfort, pain, and bloating. Preclinical studies
suggest that orally-administered plecanatide mimics the function of
uroguanylin, acting locally in the proximal intestine to stimulate secretion of
fluid, thereby facilitating bowel movements and ameliorating GI inflammation.
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,
2012 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.
Media Contact:
Janet Skidmore
Mobile (during DDW): 215-429-2917
Office: 215-658-4915
skidmorecomm@earthlink.net
Investor Contact:
Danielle Spangler
The Trout Group
Office: 646-378-2924
synergy@troutgroup.com
News Source: NASDAQ OMX
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DGAP-News: Synergy Pharmaceuticals Presents Plecanatide Results From a Large Multicenter Clinical Study at Late-Breaking Abstract Session During Digestive Disease Week 2013
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