Synergy Pharmaceuticals Reports Second Quarter And First Half 2014 Financial Results
8/12/2014 8:35:41 AM
NEW YORK--(BUSINESS WIRE)--Synergy Pharmaceuticals Inc. (NASDAQ:SGYP), today reported its financial results and business update for the three and six months ended June 30, 2014.
Key Development Highlights:
* On April 28, 2014, we announced the start of our second pivotal phase 3 clinical trial to confirm the safety and efficacy of plecanatide, our lead uroguanylin analog and once-daily oral tablet, in adult patients with chronic idiopathic constipation (CIC). This study is running in parallel with the first pivotal phase 3 CIC trial that was initiated in November 2013 and achieved the halfway mark for total enrollment on July 14, 2014. The CIC registration program includes two randomized, double-blind clinical trials to compare a 12-week regimen of plecanatide (3.0 and 6.0 mg) versus placebo in adult patients with CIC. The primary endpoint for the two pivotal trials is the proportion of patients who are overall responders for the 12-week treatment period. An overall responder for CIC is defined as a weekly responder for at least 9 out of the 12 treatment weeks, including at least 3 of the last 4 weeks. A weekly responder is defined as a patient who has = 3 CSBMs per week and an increase from baseline of = 1 CSBM for that week. Top-line data for the first CIC pivotal trial is expected in the second quarter of 2015.
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