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

  • 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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Synergy Pharmaceuticals, Inc.