Synergy Pharmaceuticals Inc.
) completed the enrolment process for its phase IIb clinical
study on its lead pipeline candidate, plecanatide. Plecanatide is
being developed for the treatment of patients suffering from
irritable bowel syndrome with constipation (IBS-C).
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The study will be evaluating the change in the mean number of
complete spontaneous bowel movement (CSBM) from baseline over the
12-week treatment period. The trial, conducted at roughly 70
sites in the U.S., will study four doses of plecanatide (0.3mg,
1.0mg, 3.0mg, 9.0mg) along with a placebo arm in patients
suffering from IBS-C. The company is expecting top-line
data from the study in the second quarter of 2014.
We remind investors that plecanatide is being developed for other
indications as well. In Nov 2013, the company initiated a phase
III study (n~1350) on plecanatide in adults suffering from
chronic idiopathic constipation (CIC). The phase III study is
evaluating a dose-ranging regimen of plecanatide in comparison to
placebo in patients suffering from CIC. The primary objective of
the study is to assess the overall responders for the 12-week
Apart from plecanatide, Synergy Pharma also has SP-333 in its
pipeline. The candidate is being developed for the treatment of
patients suffering from opioid-induced constipation in a phase II
study. We are encouraged by Synergy Pharma's progress with its
pipeline so far. Currently, Synergy Pharma has no approved
products. Consequently, its pipeline must deliver to sustain
growth. We expect investor focus to stay on updates regarding
Synergy Pharma's pipeline going forward.
We note that the constipation market currently includes
Synergy Pharma currently carries a Zacks Rank #2 (Buy). Some
other stocks worth considering include
). Jazz Pharma holds a Zacks Rank #1 (Strong Buy).