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January 2, 2013
05:10 EDTSGYPSynergy announces possitive results from plecanatide Phase IIb/III trial
Synergy Pharmaceuticals announced that plecanatide, its investigational oral drug for the treatment of chronic idiopathic constipation, or CIC, was well tolerated and met the primary and key secondary endpoints of a Phase IIb/III clinical study. Full study results will be presented at a major scientific meeting this year. The randomized, double-blind, placebo-controlled, repeat-dose, dose-ranging study was designed to determine whether plecanatide could increase the number of complete spontaneous bowel movements, or CSBM's, and impact other parameters such as stool consistency, straining and time to first bowel movement in patients with CIC. The 12-week study, which included 951 CIC patients at 113 clinical sites in the United States, evaluated 3 doses of plecanatide plus a placebo arm. Evidence of increasing efficacy was seen at increasing dose levels. Notably, the 3 mg dose in the current trial demonstrated a 19% overall responder rate, as well as demonstrating a mean increase in CSBMs over the 12-week treatment period of 2.13. In addition, statistically significant improvements were seen in key secondary endpoints. The incidence of diarrhea at 3 mg was observed to be 9.7% .
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October 21, 2014
06:06 EDTSGYPSynergy Pharm' presents positive data from phase 2b study of plecanatide
Synergy Pharmaceuticals announced the presentation of results from a phase 2b dose-ranging study assessing plecanatide’s safety and efficacy in 424 adult patients with irritable bowel syndrome with constipation. Data presented at ACG demonstrate that plecanatide, once-daily oral tablet, significantly improved complete spontaneous bowel movement frequency, bowel habits, treatment satisfaction and significantly reduced abdominal pain in patients with IBS-C throughout the 12 week treatment period. Notably, patients taking 3.0 and 9.0 mg plecanatide showed statistically significant improvement in the Overall Responder rate, a secondary analysis in this study and the endpoint required for FDA approval in IBS-C.

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