Synergy Pharma's plecanatide successful in late-stage trial; shares up 50% premarket

|About: Synergy Pharmaceutical... (SGYP)|By:, SA News Editor

Small cap Synergy Pharmaceuticals (NASDAQ:SGYP) is up 50% premarket on light volume in response to its announcement of positive results in a Phase 3 clinical trial evaluating plecanatide for the treatment of patients with chronic ideopathic constipation (CIC).

Preliminary analysis shows that both doses of plecanatide, 3 mg and 6 mg, met the primary endpoint of the proportion of patients in the intent-to-treat population who were durable overall responders versus placebo during the 12-week treatment period. Specifically, the results were: 3 mg arm: 21.0%; 6 mg arm: 19.5%; placebo: 10.2% (p<0.001).

The durable overall responder endpoint is the current FDA metric for approval for CIC. Plecanatide would be the first drug cleared under this more stringent criterion.

Plecanatide is an analog of uroguanylin, a gastrointestinal hormone produced in the small intestine that plays a key role in the normal functioning of the digestive tract.

The company intends to file an New Drug Application (NDA) with the FDA in Q4.

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