Top-line data for the first pivotal phase 3 CIC trial expected in the second quarter 2015
NEW YORK, NY, USA I July 14, 2014 I Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced that it has reached the halfway mark for total enrollment in the first pivotal phase 3 trial of plecanatide in patients with chronic idiopathic constipation (CIC).
The trial is currently being conducted at 180 sites and has randomized approximately 675 CIC patients. This is the first of two ongoing pivotal phase 3 trials designed to confirm the efficacy and safety of both 3.0 mg and 6.0 mg plecanatide doses versus placebo in CIC patients. Synergy announced the initiation of its second phase 3 CIC trial in April 2014.
The Company plans to release top-line data from the first phase 3 CIC trial in the second quarter of 2015. For more information on this trial, please visit http://clinicaltrials.gov/ct2/show/NCT01982240?term=plecanatide&rank=2
About Plecanatide
Plecanatide is Synergy’s lead uroguanylin analog in late-stage clinical development to treat patients with CIC and IBS-C. Uroguanylin is a natural gastrointestinal (GI) hormone produced by humans in the small intestine and plays a key role in regulating the normal functioning of the digestive tract through its activity on the guanylate cyclase-C (GC-C) receptor. The GC-C receptor is known to be a primary source for stimulating a variety of beneficial physiological responses. Orally administered plecanatide mimics uroguanylin’s functions by binding to and activating the GC-C receptor to stimulate fluid and ion transit required for normal bowel function. Synergy has successfully completed a phase 2b trial of plecanatide in 951 patients with CIC and is currently enrolling patients in two pivotal phase 3 CIC trials. The company also recently announced positive top-line data results from a phase 2b dose-ranging study with plecanatide in patients with IBS-C. Synergy plans to initiate its pivotal phase 3 IBS-C program in the fourth quarter of 2014.
About Synergy Pharmaceuticals
Synergy Pharmaceuticals (NASDAQ: SGYP) is a biopharmaceutical company focused on the development of novel therapies based on the natural human hormone, uroguanylin, to treat GI diseases and disorders. Synergy has created two unique analogs of uroguanylin – plecanatide and SP-333 – designed to mimic the natural hormone’s activity on the GC-C receptor and target a variety of GI conditions. SP-333 is currently in phase 2 development for opioid-induced constipation and is also being explored for ulcerative colitis. For more information, please visit www.synergypharma.com.
SOURCE: Synergy Pharmaceuticals
Post Views: 25
Top-line data for the first pivotal phase 3 CIC trial expected in the second quarter 2015
NEW YORK, NY, USA I July 14, 2014 I Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced that it has reached the halfway mark for total enrollment in the first pivotal phase 3 trial of plecanatide in patients with chronic idiopathic constipation (CIC).
The trial is currently being conducted at 180 sites and has randomized approximately 675 CIC patients. This is the first of two ongoing pivotal phase 3 trials designed to confirm the efficacy and safety of both 3.0 mg and 6.0 mg plecanatide doses versus placebo in CIC patients. Synergy announced the initiation of its second phase 3 CIC trial in April 2014.
The Company plans to release top-line data from the first phase 3 CIC trial in the second quarter of 2015. For more information on this trial, please visit http://clinicaltrials.gov/ct2/show/NCT01982240?term=plecanatide&rank=2
About Plecanatide
Plecanatide is Synergy’s lead uroguanylin analog in late-stage clinical development to treat patients with CIC and IBS-C. Uroguanylin is a natural gastrointestinal (GI) hormone produced by humans in the small intestine and plays a key role in regulating the normal functioning of the digestive tract through its activity on the guanylate cyclase-C (GC-C) receptor. The GC-C receptor is known to be a primary source for stimulating a variety of beneficial physiological responses. Orally administered plecanatide mimics uroguanylin’s functions by binding to and activating the GC-C receptor to stimulate fluid and ion transit required for normal bowel function. Synergy has successfully completed a phase 2b trial of plecanatide in 951 patients with CIC and is currently enrolling patients in two pivotal phase 3 CIC trials. The company also recently announced positive top-line data results from a phase 2b dose-ranging study with plecanatide in patients with IBS-C. Synergy plans to initiate its pivotal phase 3 IBS-C program in the fourth quarter of 2014.
About Synergy Pharmaceuticals
Synergy Pharmaceuticals (NASDAQ: SGYP) is a biopharmaceutical company focused on the development of novel therapies based on the natural human hormone, uroguanylin, to treat GI diseases and disorders. Synergy has created two unique analogs of uroguanylin – plecanatide and SP-333 – designed to mimic the natural hormone’s activity on the GC-C receptor and target a variety of GI conditions. SP-333 is currently in phase 2 development for opioid-induced constipation and is also being explored for ulcerative colitis. For more information, please visit www.synergypharma.com.
SOURCE: Synergy Pharmaceuticals
Post Views: 25
