Synergy Pharma Stock Up After Chronic Idiopathic Constipation Trial Results

(RTTNews) - Synergy Pharmaceuticals Inc.'s (SGYP) first of two pivotal phase III clinical trials evaluating the efficacy and safety of two different doses of investigational oral drug Plecanatide in chronic idiopathic constipation has met the primary endpoint.

According to the trial results, Plecanatide at 3.0 mg and 6.0 mg doses demonstrated statistical significance in the proportion of patients in the intention-to-treat population who were *durable overall responders compared to placebo during the 12-week treatment period. Plecanatide also proved to be safe and well tolerated at both doses in the study.

*A durable overall responder is defined as a patient who fulfills both greater than or equal to 3 complete spontaneous bowel movements, or CSBM, per week plus an increase of greater than or equal to 1 CSBM from baseline in the same week, for 9 out of the 12 treatment weeks. In addition, the same patient must be an overall responder for at least 3 of the last 4 treatment weeks in order to be considered a durable overall responder.

The most common adverse event observed in the treatment arms of the trial was diarrhea, which occurred in 5.9% of patients in 3.0 mg and 5.5% of patients in 6.0 mg dose groups compared to 1.3% of placebo-treated patients.

The top-line data from the second phase III trial of Plecanatide in chronic idiopathic constipation are expected to be announced in the first half of the third quarter of this year. The company plans to file its first new drug application with Plecanatide in the chronic idiopathic constipation indication in the fourth quarter of this year.

SGYP closed Tuesday's trading at $4.64, down 5.31%. In premarket trading on Wednesday, the stock is up 28.23% at $5.95.