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Synergy Pharmaceuticals Files IND for SP-333, a Developmental Drug for Gastrointestinal Diseases
12 Sep, 2012 14:35 CET
Synergy Pharmaceuticals
Press release
Synergy Pharmaceuticals Files IND for SP-333, a Developmental Drug for
Gastrointestinal Diseases
NEW YORK, 2012-09-12 14:35 CEST (GLOBE NEWSWIRE) -- Synergy Pharmaceuticals,
Inc. (Nasdaq:SGYP), a developer of new drugs to treat gastrointestinal (GI)
disorders and diseases, announced today that an Investigational New Drug (IND)
application was submitted on September 7, 2012 for clinical evaluation of
SP-333 to treat inflammatory bowel disease (IBD). SP-333 is a second-generation
guanylate cyclase-C (GC-C) agonist with the potential to treat GI disorders and
diseases.
"SP-333, to our knowledge, represents the most potent and stable uroguanylin
analog ever developed," stated Dr. Gary S. Jacob, President and CEO of Synergy
Pharmaceuticals. "The submission of the IND on SP-333 is a major milestone for
the company, as it broadens our clinical portfolio of GC-C agonists for
treatment of GI disorders and diseases."
"The science behind SP-333 marks a new approach to the treatment of GI
inflammatory diseases," said Dr. Kunwar Shailubhai, Chief Scientific Officer of
Synergy Pharmaceuticals. "We are excited with SP-333's impressive
anti-inflammatory activity. In studies with experimental models of colitis in
mice, SP-333 at an oral dose as low as 0.05 mg/kg body weight demonstrated
superior anti-inflammatory activity compared to 5-aminosalicylic acid (5-ASA)
given at a dose of 100 mg/kg."
About SP-333
SP-333 is a synthetic analog of uroguanylin, a natriuretic hormone which is
normally produced in the body's intestinal tract. Deficiency of uroguanylin is
likely to be one of the primary reasons associated with formation of polyps as
well as debilitating and difficult-to-treat GI inflammatory disorders such as
ulcerative colitis and Crohn's disease. Orally-administered SP-333 binds to and
activates guanylate cyclase C (GC-C) expressed on epithelial cells lining the
GI mucosa, resulting in stimulation of cyclic GMP in target tissues. SP-333
has been found to be highly stable against proteolysis in simulated intestinal
fluid for up to 24 hours. Its enhanced stability makes this peptide an
extremely potent GC-C agonist in animal studies in mice and monkeys, promoting
bowel movement in monkeys, and ameliorating GI inflammation in mice,
respectively.
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
constipation-predominant irritable bowel syndrome, with the first trial in
IBS-C patients planned for the second half of 2012. 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, which are 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
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.
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,
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.
Investor Contact Information:
Danielle Spangler
The Trout Group
[email protected]
(646) 378-2924
Synergy Pharmaceuticals Files IND for SP-333, a Developmental Drug for Gastrointestinal Diseases
12 Sep, 2012 14:35 CET
Synergy Pharmaceuticals
Press release
Synergy Pharmaceuticals Files IND for SP-333, a Developmental Drug for
Gastrointestinal Diseases
NEW YORK, 2012-09-12 14:35 CEST (GLOBE NEWSWIRE) -- Synergy Pharmaceuticals,
Inc. (Nasdaq:SGYP), a developer of new drugs to treat gastrointestinal (GI)
disorders and diseases, announced today that an Investigational New Drug (IND)
application was submitted on September 7, 2012 for clinical evaluation of
SP-333 to treat inflammatory bowel disease (IBD). SP-333 is a second-generation
guanylate cyclase-C (GC-C) agonist with the potential to treat GI disorders and
diseases.
"SP-333, to our knowledge, represents the most potent and stable uroguanylin
analog ever developed," stated Dr. Gary S. Jacob, President and CEO of Synergy
Pharmaceuticals. "The submission of the IND on SP-333 is a major milestone for
the company, as it broadens our clinical portfolio of GC-C agonists for
treatment of GI disorders and diseases."
"The science behind SP-333 marks a new approach to the treatment of GI
inflammatory diseases," said Dr. Kunwar Shailubhai, Chief Scientific Officer of
Synergy Pharmaceuticals. "We are excited with SP-333's impressive
anti-inflammatory activity. In studies with experimental models of colitis in
mice, SP-333 at an oral dose as low as 0.05 mg/kg body weight demonstrated
superior anti-inflammatory activity compared to 5-aminosalicylic acid (5-ASA)
given at a dose of 100 mg/kg."
About SP-333
SP-333 is a synthetic analog of uroguanylin, a natriuretic hormone which is
normally produced in the body's intestinal tract. Deficiency of uroguanylin is
likely to be one of the primary reasons associated with formation of polyps as
well as debilitating and difficult-to-treat GI inflammatory disorders such as
ulcerative colitis and Crohn's disease. Orally-administered SP-333 binds to and
activates guanylate cyclase C (GC-C) expressed on epithelial cells lining the
GI mucosa, resulting in stimulation of cyclic GMP in target tissues. SP-333
has been found to be highly stable against proteolysis in simulated intestinal
fluid for up to 24 hours. Its enhanced stability makes this peptide an
extremely potent GC-C agonist in animal studies in mice and monkeys, promoting
bowel movement in monkeys, and ameliorating GI inflammation in mice,
respectively.
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
constipation-predominant irritable bowel syndrome, with the first trial in
IBS-C patients planned for the second half of 2012. 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, which are 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
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.
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,
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.
Investor Contact Information:
Danielle Spangler
The Trout Group
[email protected]
(646) 378-2924
