Synergy Pharma Initiates First Phase 3 Clinical Trial Of Plecanatide For IBS-C

(RTTNews) - Synergy Pharmaceuticals, Inc. (SGYP) Thursday said it has initiated the first of two planned pivotal phase 3 clinical trials evaluating the safety and efficacy of 3.0 and 6.0 mg plecanatide, once-daily oral tablets, for the treatment of irritable bowel syndrome with constipation, or IBS-C.

The company said it is also evaluating 3.0 and 6.0 mg doses of plecanatide in two ongoing pivotal phase 3 trials for chronic idiopathic constipation , or CIC, scheduled to read out top-line results in second quarter and third quarter of 2015.

Plecanatide is Synergy's lead uroguanylin analog in late-stage clinical development to treat patients with CIC and IBS-C.

According to the firm, the randomized, 12-week, double-blind, placebo-controlled pivotal phase 3 IBS-C trial will be conducted in the U.S., and is expected to enroll about 1050 adult patients with IBS-C.

Synergy plans to initiate the second pivotal phase 3 IBS-C trial with plecanatide in the first half of 2015.