Synergy Pharmaceuticals (SGYP) recently initiated a phase IIb study with plecanatide for the treatment of patients suffering from constipation-predominant irritable bowel syndrome (IBS-C). Synergy Pharma will be enrolling 350 patients suffering from IBS-C around 70 sites in the US. These patients will be treated with any one of the four doses of plecanatide (0.3, 1.0, 3.0, or 9.0 mg) or placebo for 12 weeks.
The trial will be evaluating the average change in complete spontaneous bowel movements (CSBM's) during the trial period in comparison to their baseline weekly CSBM rate that was established during the screening phase of the study. In addition to this, Synergy Pharma will be evaluating spontaneous bowel movements (SBM's) and daily abdominal pain, discomfort along with bloating scores and impact of the candidate on disease-specific quality of life measures during the study.
The IBS-C market already has players like Takeda Pharmaceutical Company Limited (TKPYY), ForestLaboratories Inc. (FRX) and Ironwood Pharmaceuticals (IRWD).
We note that Synergy Pharma is conducting an independent study on plecanatide for the treatment of patients suffering from chronic idiopathic constipation. The company expects to complete the study soon and report top-line results within a few weeks.
Apart from plecanatide, Synergy Pharma also completed a phase I clinical trial on SP-333, a guanylate cyclase C (GC-C) agonist, being developed for the treatment of ulcerative colitis (UC) and other GI diseases. The company now expects to initiate a multi-dose, dose-escalation trial in patients by January 2013.
Synergy Pharma currently carries a Zacks #3 Rank (Hold) in the short run. Meanwhile, Ironwood Pharma carries a Zacks #2 Rank (Buy).