Synergy Pharmaceuticals Inc. (SGYP) completed patient enrollment for its phase II study on SP-333 being developed for the treatment of patients suffering from opioid-induced constipation (:OIC).
The phase dose-ranging II study is evaluating a 4-week regimen of SP-333 (1.0 mg, 3.0 mg and 6.0 mg) compared to placebo in patients who have been taking opioid analgesics for chronic, non-cancer pain for a minimum of three months.
Synergy Pharma enrolled 260 patients suffering from 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. Top-line results from the study are expected in the final quarter of 2014.
Synergy Pharma announced earlier in the month that its lead candidate, plecanatide, is expected to enter into phase III development in the fourth quarter of 2014 for the treatment of irritable bowel syndrome with constipation. The announcement was made after successfully completing an end-of-phase II meeting with the FDA. The phase III study will consist of two registration studies (n=1050 each) in patients receiving either placebo or plecanatide.
Synergy Pharma is developing plecanatide for the chronic idiopathic constipation (CIC.TO) indication as well. Plecanatide is currently in phase III development in patients suffering from CIC.
We are encouraged by Synergy Pharma’s progress with its pipeline. However, 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).