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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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December 18, 2014
06:15 EDTSGYPSynergy Pharmaceuticals initiates Phase 3 trial for irritable bowel syndrome
Synergy Pharmaceuticals Inc. initiated the first of two planned pivotal phase 3 clinical trials evaluating the safety and efficacy of 3.0 and 6.0 mg plecanatide, once-daily oral tablets, for the treatment of irritable bowel syndrome with constipation. Synergy is also evaluating 3.0 and 6.0 mg doses of plecanatide in two ongoing pivotal phase 3 trials for chronic idiopathic constipation, scheduled to read out top-line results in Q2 and Q3 2015. The pivotal phase 3 trial is expected to enroll approximately 1050 adult patients with IBS-C. The primary efficacy endpoint for this trial is the percentage of patients who are Overall Responders during the 12 week treatment period. Synergy plans to initiate the second pivotal phase 3 IBS-C trial with plecanatide in 1H15.

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