Synergy Reports Positive Results From First Phase 3 Trial Of Plecanatide

(RTTNews) - Synergy Pharmaceuticals Inc. (SGYP) announced positive top-line results from the first of two pivotal phase 3 clinical trials evaluating the efficacy and safety of two different plecanatide treatment doses (3.0 mg and 6.0 mg), taken as a tablet once-a-day, in 1,346 adult patients with chronic idiopathic constipation. The company said preliminary analysis of the data indicates that both plecanatide 3.0 mg and 6.0 mg doses met the study's primary endpoint and 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.

The company said plecanatide was safe and well tolerated at both doses; the most common adverse event was diarrhea.

Synergy plans to announce top-line data results from the second phase 3 CIC trial with plecanatide in the first half of third quarter, 2015. The company plans to file its first new drug application with plecanatide in the chronic idiopathic constipation indication in the fourth quarter of the current year.