) 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
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
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
Synergy Pharma currently carries a Zacks #3 Rank (Hold) in the
short run. Meanwhile, Ironwood Pharma carries a Zacks #2 Rank
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