Synergy Pharmaceuticals Inc.
) intends to start a pivotal phase III study on its lead pipeline
candidate, plecanatide, in the fourth quarter of 2014 after
successfully completing an end-of-phase II meeting with the FDA.
Plecanatide is being developed for the treatment of irritable bowel
syndrome with constipation (IBS-C). The phase III study will
consist of two registration studies (n=1050 each) in patients
receiving either placebo or plecanatide.
In Apr 2014, Synergy Pharma reported positive top-line results from
a phase IIb dose-ranging study on plecanatide for treating patients
suffering from IBS-C. Results showed that plecanatide was
successful in showing statistically significant improvement in
complete spontaneous bowel movement frequency. The candidate was
also safe and well tolerated at all doses during the study.
Apart from the IBS-C indication, Synergy Pharma is developing
plecanatide for the chronic idiopathic constipation (CIC)
indication as well. In Apr 2014, the company started its second
phase III study on plecanatide in adults suffering from CIC. The
first study was initiated in Nov 2013. The phase III studies are
evaluating a dose-ranging regimen of plecanatide in comparison to
placebo in patients suffering from CIC.
We are encouraged by Synergy Pharma's progress with its lead
pipeline candidate. The successful development of plecanatide is
important for the company. Synergy Pharma also has SP-333 in its
pipeline being developed for the treatment of opioid-induced
constipation in a phase II study. The constipation market includes
Synergy Pharma currently carries a Zacks Rank #1 (Strong Buy).
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