Synergy Pharmaceuticals Inc.
) recently announced that it has reached an agreement with the
U.S. Food and Drug Administration (FDA) on the clinical
development plan for its pipeline candidate plecanatide.
We note that Synergy Pharma is developing plecanatide for the
treatment of patients suffering from chronic idiopathic
As per the agreement with the FDA, Synergy Pharma will
initiate a phase III study by year end to evaluate the safety and
efficacy of plecanatide in CIC patients.
The FDA has also agreed on the design, duration, size and
primary and secondary efficacy endpoints of the phase III
We are encouraged by the pipeline progress at Synergy Pharma.
In May 2013, Synergy Pharma 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.
We remind investors that 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
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 stiff competition on
approval. The constipation market already includes
Synergy Pharma currently carries a Zacks Rank #3 (Hold). Right
) looks attractive with a Zacks Rank #2 (Buy).
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