Synergy Pharmaceuticals Inc. recently announced positive results from a multicenter trial which evaluated its pipeline candidate plecanatide for treating patients suffering from chronic idiopathic constipation (CIC). The encouraging data was presented at the Digestive Disease Week in the US.
The 12-week study (n=951) was conducted to evaluate the efficacy and safety of three oral doses of plecanatide compared to placebo.
The trial tested the ability of plecanatide to increase the number of complete spontaneous bowel movements (CSBMs) along with improving other bowel measures such as stool consistency and straining.
Synergy Pharma observed statistically significant improvement in the number of CSBMs among patients, who were administered three doses of plecanatide. The study also showed that patients experienced improvements in other symptoms of chronic constipation as well, including decreased stool hardness and straining. An improvement in the quality of life was observed in CIC patients treated with plecanatide.
Synergy Pharma now plans to move forward with the development of plecanatide for the treatment of CIC and intends to initiate pivotal trials in the second half of 2013.
We remind investors Synergy Pharma is also developing plecanatide for the treatment of irritable bowel syndrome with constipation (IBS-C). The company initiated the first trial in IBS-C patients in late 2012. Currently, a phase IIb trial evaluating plecanatide in IBS-C patients is underway and Synergy Pharma expects to release top-line data from this trial in the first quarter of 2014.
We expect investor focus to remain on updates regarding the future development of plecanatide. The successful development and commercialization of plecanatide would be a major positive for Synergy Pharma, which currently has no approved drug.
However, plecanatide is expected to face competition on approval. The constipation market already includes Ironwood Pharmaceuticals/ Forest Laboratories’ (IRWD - Analyst Report)/ Linzess for treating adults suffering from IBS-C or CIC.
Synergy Pharma currently carries a Zacks Rank #4 (Sell). Right now, Salix Pharmaceuticals Ltd. looks attractive with a Zacks Rank #1 (Strong Buy).