Synergy Pharmaceuticals Inc. (SGYP) 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.TO) 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 Ironwood Pharmaceuticals/Actavis’ (IRWD/ACT) Linzess.
Synergy Pharma currently carries a Zacks Rank #1 (Strong Buy). Among other stocks worth considering is Zacks Ranked #1 (Strong Buy) Actelion Ltd. (ALIOF).