Top-line data for the SP-333 phase 2 OIC trial expected in the fourth quarter of 2014
NEW YORK, NY, USA I July 17, 2014 I Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced that it has successfully completed patient enrollment for its phase 2 trial of SP-333, Synergy’s next-generation uroguanylin analog, in patients with opioid-induced constipation (OIC).
The multi-center, randomized, double-blind clinical trial is designed to compare a 4-week dose-ranging regimen of once-daily oral SP-333 (1.0 mg, 3.0 mg and 6.0 mg) against placebo in patients taking opioid analgesics for chronic, non-cancer pain for at least three months. The study will evaluate approximately 260 patients with OIC who have less than 3 spontaneous bowel movements (SBMs) per week and who experience constipation related symptoms. The primary endpoint of the study is mean change from baseline in the number of SBMs during Week 4 of the Treatment Period.
Synergy plans to release top-line data from this trial in the fourth quarter of this year. For more information, please visit http://clinicaltrials.gov/ct2/show/NCT01983306?term=sp-333&rank=1
About SP-333
SP-333 is Synergy’s next-generation uroguanylin analog in development for the treatment of OIC and mild-to-moderate ulcerative colitis. SP-333 is designed to be a highly potent and stable version of the naturally occurring gastrointestinal (GI) hormone, uroguanylin, and resistant to proteolysis in gastric intestinal fluids. SP-333 has completed phase 1 single and multiple ascending dose studies in healthy volunteers and is currently in a phase 2 clinical trial for OIC. Synergy is also developing a unique formulation of SP-333 for treating GI inflammation in patients with ulcerative colitis.
About Synergy Pharmaceuticals
Synergy Pharmaceuticals (NASDAQ:SGYP) is a biopharmaceutical company focused on the development of novel therapies based on the naturally occurring 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 intestinal guanylate cyclase-C (GC-C) receptor and target a variety of GI conditions. Plecanatide is currently in two pivotal phase 3 trials for chronic idiopathic constipation (CIC) and recently reached the halfway mark for patient enrollment in the first CIC registration trial. Synergy plans to release topline data from the first CIC registration trial in the second quarter of 2015. In April 2014, the Company announced positive top-line data results with plecanatide in a phase 2b study for irritable bowel syndrome with constipation (IBS-C). Synergy plans to initiate its pivotal phase 3 IBS-C program with plecanatide in the fourth quarter of this year. For more information, please visit www.synergypharma.com.
SOURCE: Synergy Pharmaceuticals
Post Views: 81
Top-line data for the SP-333 phase 2 OIC trial expected in the fourth quarter of 2014
NEW YORK, NY, USA I July 17, 2014 I Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced that it has successfully completed patient enrollment for its phase 2 trial of SP-333, Synergy’s next-generation uroguanylin analog, in patients with opioid-induced constipation (OIC).
The multi-center, randomized, double-blind clinical trial is designed to compare a 4-week dose-ranging regimen of once-daily oral SP-333 (1.0 mg, 3.0 mg and 6.0 mg) against placebo in patients taking opioid analgesics for chronic, non-cancer pain for at least three months. The study will evaluate approximately 260 patients with OIC who have less than 3 spontaneous bowel movements (SBMs) per week and who experience constipation related symptoms. The primary endpoint of the study is mean change from baseline in the number of SBMs during Week 4 of the Treatment Period.
Synergy plans to release top-line data from this trial in the fourth quarter of this year. For more information, please visit http://clinicaltrials.gov/ct2/show/NCT01983306?term=sp-333&rank=1
About SP-333
SP-333 is Synergy’s next-generation uroguanylin analog in development for the treatment of OIC and mild-to-moderate ulcerative colitis. SP-333 is designed to be a highly potent and stable version of the naturally occurring gastrointestinal (GI) hormone, uroguanylin, and resistant to proteolysis in gastric intestinal fluids. SP-333 has completed phase 1 single and multiple ascending dose studies in healthy volunteers and is currently in a phase 2 clinical trial for OIC. Synergy is also developing a unique formulation of SP-333 for treating GI inflammation in patients with ulcerative colitis.
About Synergy Pharmaceuticals
Synergy Pharmaceuticals (NASDAQ:SGYP) is a biopharmaceutical company focused on the development of novel therapies based on the naturally occurring 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 intestinal guanylate cyclase-C (GC-C) receptor and target a variety of GI conditions. Plecanatide is currently in two pivotal phase 3 trials for chronic idiopathic constipation (CIC) and recently reached the halfway mark for patient enrollment in the first CIC registration trial. Synergy plans to release topline data from the first CIC registration trial in the second quarter of 2015. In April 2014, the Company announced positive top-line data results with plecanatide in a phase 2b study for irritable bowel syndrome with constipation (IBS-C). Synergy plans to initiate its pivotal phase 3 IBS-C program with plecanatide in the fourth quarter of this year. For more information, please visit www.synergypharma.com.
SOURCE: Synergy Pharmaceuticals
Post Views: 81
