Synergy Pharmaceuticals Inc. (SGYP) currently has no approved products. The company has progressed well with its pipeline in the last few quarters. SP-333 is one of the important candidates in Synergy Pharma’s pipeline, being developed for the treatment of inflammatory bowel diseases (:IBD), like ulcerative colitis and opioid-induced constipation (OIC).
Last week, Synergy Pharma initiated a phase II study on SP-333. The study will evaluate the safety and efficacy of SP-333 in adults suffering from OIC. The phase II study (dose-ranging study) will be evaluating a 4-week regimen of SP-333 in patients who have been taking opioid analgesics for chronic, non-cancer pain for a minimum of three months.
Synergy Pharma intends to enrol 260 patients with 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.
We note that earlier in the year Synergy Pharma successfully completed a phase I placebo-controlled, dose-escalating, multiple-dose study on SP-333 in patients with IBD.
Another interesting candidate at Synergy Pharma is plecanatide. Plecanatide is currently in a phase IIb study for the treatment of patients suffering from irritable bowel syndrome with constipation (IBS-C). Synergy Pharma expects to enrol the last patient for the study by year end and release top-line data from this study in the first quarter of 2014.
We expect investor focus to remain on updates regarding the development of the company’s pipeline. The successful development and commercialization of the candidates would be a major positive for Synergy Pharma. The constipation market currently has products like Ironwood Pharmaceuticals/Forest Laboratories’ (IRWD)/ (FRX) Linzess.
Synergy Pharma currently carries a Zacks Rank #3 (Hold). Right now, Actelion Ltd. (ALIOF) looks attractive with a Zacks Rank #1 (Strong Buy).