Synergy Pharmaceuticals Achieves Halfway Mark in Enrollment on Plecanatide Phase II/III Trial in Chronic Idiopathic Constipation
Synergy Pharmaceuticals
09.04.2012 13:15
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NEW YORK, 2012-04-09 13:15 CEST (GLOBE NEWSWIRE) --
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
News Source: NASDAQ OMX
09.04.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Synergy Pharmaceuticals
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US8716393082
WKN:
End of Announcement DGAP News-Service
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Synergy Pharmaceuticals
09.04.2012 13:15
---------------------------------------------------------------------------
NEW YORK, 2012-04-09 13:15 CEST (GLOBE NEWSWIRE) --
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
News Source: NASDAQ OMX
09.04.2012 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------------
Language: English
Company: Synergy Pharmaceuticals
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US8716393082
WKN:
End of Announcement DGAP News-Service
---------------------------------------------------------------------------