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December 28, 2012
05:37 EDTSGYPSynergy Pharmaceuticals completes Phase I trial of SP-333
Synergy Pharmaceuticals announced the successful completion of a Phase I single-ascending-dose clinical trial of SP-333, a guanylate cyclase C, or GC-C, agonist designed to treat ulcerative colitis, or UC, and other GI diseases. SP-333 has exhibited potent anti-inflammatory activity in animal studies of colitis, displaying a novel mechanism-of-action that the Company believes can provide a new way to treat UC patients with mild to moderate disease. This study was designed as a placebo-controlled, dose-escalating, single-dose trial in healthy adult volunteers, primarily focused on exploring the safety profile of SP-333. Eight cohorts were dosed, ranging from 0.1 to 60 mg of SP-333. There were no serious or unexpected adverse events in this study. Importantly, SP-333 exhibited gastrointestinal pharmacodynamic characteristics that were anticipated based on its GC-C receptor agonist activity. A multi-dose, dose-escalation trial in volunteers is planned to start in January.
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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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