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
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
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'
) Linzess for treating adults suffering from IBS-C or CIC.
Synergy Pharma currently carries a Zacks Rank #4 (Sell). Right
Salix Pharmaceuticals Ltd. (
looks attractive with a Zacks Rank #1 (Strong Buy).
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