Synergy Pharmaceuticals Inc. (SGYP) 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).
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 treatment period.
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 Ironwood Pharmaceuticals/Forest Laboratories’ (IRWD)/(FRX) Linzess.
Synergy Pharma currently carries a Zacks Rank #2 (Buy). Some other stocks worth considering include Jazz Pharmaceuticals (JAZZ). Jazz Pharma holds a Zacks Rank #1 (Strong Buy).
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