"...aus den gängigen US-Medien:
Synergy Pharmaceuticals Inc. January 29, 2015 6:00 AM
NEW YORK--(BUSINESS WIRE)--
Synergy Pharmaceuticals Inc. (SGYP) today announced that it has successfully completed patient enrollment in the second of two pivotal phase 3 trials evaluating the safety and efficacy of two plecanatide doses (3.0 and 6.0 mg) in patients with chronic idiopathic constipation (CIC). Synergy announced that it had completed patient enrollment in the first phase 3 CIC trial on January 8, 2015.
Each of the two randomized, 12-week, double-blind, placebo-controlled phase 3 trials are evaluating plecanatide, once-daily oral tablets, in approximately 1350 adult patients with CIC. The primary endpoint is the proportion of patients who are Overall Responders during the 12-week treatment period. An Overall Responder is a patient who fulfills both ≥ 3 complete spontaneous bowel movements (CSBMs) per week plus an increase of ≥ 1 CSBM from baseline in the same week, for 9 out of the 12 weeks, including ≥ 3 of the last 4 weeks. Plecanatide has met this endpoint and demonstrated statistical significance at the 3.0 mg dose in a phase 2b CIC trial evaluating 951 patients with CIC.
Synergy expects top-line data results from the first phase 3 CIC trial in 2Q 2015 and top-line data results from the second phase 3 CIC trial in 3Q 2015. The company plans to file its first NDA with plecanatide in the CIC indication in the fourth quarter of this year. Plecanatide 3.0 and 6.0 mg doses are also being evaluated in the ongoing phase 3 registration program for irritable bowel syndrome with constipation (IBS-C)..."
