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