Synergy reports 'positive' top-line results from Phase 3 plecanatide trial
Synergy Pharmaceuticals announced positive top-line results from the second of two pivotal phase 3 clinical trials evaluating the efficacy and safety of plecanatide, an investigational once-daily orally-administered compound, in 1,054 adult patients with irritable bowel syndrome with constipation. Preliminary analysis of the data indicates that both plecanatide 3 mg and 6 mg doses met the study's primary endpoint and showed statistical significance in the percentage of patients who were Overall Responders compared to placebo during the 12-week treatment period. The most common adverse event was diarrhea which occurred in 5.4% of patients in 3 mg and 4.3% of patients in 6 mg dose groups compared to 0.6% of placebo-treated patients. "We are understandably very pleased with these results, and how well the data support the first pivotal phase 3 IBS-C trial which we announced recently," said Gary S. Jacob, Ph.D., Chairman and CEO of Synergy Pharmaceuticals Inc. "We have been relentless in our commitment to develop innovative treatments for the GI market. The successful phase 3 trials are a major step in our mission to better serve patients, as we believe plecanatide has the potential to be an important new treatment option for the millions of people suffering from IBS-C. I want to, in particular, acknowledge my colleagues at Synergy, my outstanding board, and the many stakeholders who have supported us throughout this clinical program." Synergy reported positive top-line data in the first phase 3 IBS-C trial with plecanatide earlier this month. The company plans to present further clinical data from both trials at an appropriate scientific meeting next year. Additionally, plecanatide is under review by the Food and Drug Administration for the treatment of chronic idiopathic constipation and the Prescription Drug User Fee Act target action date is January 29, 2017. Pending approval in the CIC indication, the company plans to file a New Drug Application Supplement with Clinical Data for plecanatide in IBS-C in Q1 2017.