Synergy Pharmaceuticals Inc.
) currently has no approved products. The company has progressed
well with its pipeline in the last few quarters. SP-333 is one of
the important candidates in Synergy Pharma's pipeline, being
developed for the treatment of inflammatory bowel diseases (IBD),
like ulcerative colitis and opioid-induced constipation (OIC).
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Last week, Synergy Pharma initiated a phase II study on SP-333.
The study will evaluate the safety and efficacy of SP-333 in
adults suffering from OIC. The phase II study (dose-ranging
study) will be evaluating a 4-week regimen of SP-333 in patients
who have been taking opioid analgesics for chronic, non-cancer
pain for a minimum of three months.
Synergy Pharma intends to enrol 260 patients with OIC who have
less than 3 spontaneous bowel movements (SBMs) per week and have
experienced constipation-related symptoms. The main objective of
the study is to evaluate the mean change from baseline in the
number of SBMs during the final week of the treatment period.
We note that earlier in the year Synergy Pharma successfully
completed a phase I placebo-controlled, dose-escalating,
multiple-dose study on SP-333 in patients with IBD.
Another interesting candidate at Synergy Pharma is plecanatide.
Plecanatide is currently in a phase IIb study for the treatment
of patients suffering from irritable bowel syndrome with
constipation (IBS-C). Synergy Pharma expects to enrol the last
patient for the study by year end and release top-line data from
this study in the first quarter of 2014.
We expect investor focus to remain on updates regarding the
development of the company's pipeline. The successful development
and commercialization of the candidates would be a major positive
for Synergy Pharma. The constipation market currently has
Synergy Pharma currently carries a Zacks Rank #3 (Hold). Right
) looks attractive with a Zacks Rank #1 (Strong Buy).