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Synergy scores in Phase 3 for 2nd indication

May 10, 2017

Synergy Pharmaceuticals Inc SGYP presented positive results from its Phase 3 study of plecanatide for the treatment of irritable bowel syndrome with constipation (IBS-C).

In two large studies, Synergy examined plecanatide, marketed as “Trulance,” in both 3 mg and 6 mg doses. Both dosages met the primary endpoint, with statistical significance, of being what the U.S. Food and Drug Administration calls an “Overall Responder.”

For this, Overall Responders were defined as those who experienced both at least a 30 percent reduction in abdominal pain and an increase of at least one spontaneous bowel movement over baseline, in the same week, for at least six of the 12 treatment weeks. In a pooled analysis of both studies, the 3 mg and 6 mg doses both met these endpoints.

As is common with many treatments for IBS-C and chronic idiopathic constipation (CIC, for which Trulance achieved FDA approval earlier this year), diarrhea was the most common adverse event reported. Discontinuation rates, however, were low at 1.2 percent and 1.4 percent for the 3 mg and 6 mg doses, respectively.

Earlier this week, the company reported positive trial data in CIC, with Trulance hitting its Phase 3 primary endpoint in that indication as well.

Trulance

Trulance, in IBS-C, could win FDA approval by year end, assuming a standard 10-month review period of its sNDA, filed March 27. The drug is already being marketed in CIC, with Rodman & Renshaw analyst Raghuram Sevaraju recently estimating its 2017 sales at $53.6 million.

Despite a slew of positive clinical news, Synergy stock has slumped thus far in 2017, down about 37 percent year-to-date. Some attribute this to investors disappointed that Synergy has yet to be scooped up by a larger pharma company.

Staying On Track

Back in December, Synergy Chief Strategy Officer Marino Garcia told Benzinga the company hoped to start 2017 with an FDA approval in CIC, launch Trulance, and “potentially end the year with another approval for the second indication, IBS-C.”

With two out of those three boxes checked, so far so good.

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