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News Breaks | | | | January 2, 2013 | | 05:10 EDT |  | SGYP | Synergy 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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| May 17, 2013 | | 10:36 EDT |  | SGYP | Leerink's major/specialty pharma analyst holds analyst/Industry conference call
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