Synergy Pharmaceuticals Inc. (SGYP) recently announced that the enrolment procedure of its phase IIb study on plecanatide has reached the halfway mark. Plecanatide is being developed for the treatment of patients suffering from irritable bowel syndrome with constipation (IBS-C).
Synergy Pharma expects to enrol a total of 350 patients suffering from IBS-C for the phase IIb study, which is being conducted around 70 sites in the US. Synergy Pharma expects to enrol the last patient for the study in the final quarter of 2013. Synergy Pharma expects to release top-line data from this study in the first quarter of 2014.
We remind investors that Synergy Pharma is also developing plecanatide for the treatment of patients suffering from chronic idiopathic constipation (:CIC). In May this year, the company reported positive results from a multicenter trial on plecanatide for the CIC indication. Synergy Pharma observed statistically significant improvement in the number of complete spontaneous bowel movements 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 intends to pursue the development of plecanatide for the treatment of CIC with pivotal trials expected to begin before Dec 31, 2013.
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.
The constipation market already has Linzess for treating adults suffering from IBS-C or CIC.
Synergy Pharma, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Biopharma companies like Jazz Pharmaceuticals Public Limited Company (JAZZ), Sarepta Therapeutics, Inc. (SRPT) and Medivation, Inc. (MDVN) currently appear to be more attractive. While Jazz Pharma and Sarepta carry a Zacks Rank #1(Strong Buy), Medivation carries a Zacks Rank #2(Buy).
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