Synergy Pharma Ends Year With Second Dose Of Positive Plecanatide Trial Results

Synergy Pharmaceuticals Inc SGYP announced after Thursday's closing bell that its drug plecanatide, a daily pill to fight irritable bowel syndrome, had achieved positive top-line results from the second of two pivotal phase 3 clinical trials evaluating the efficacy and safety of the drug.

Plecanatide is under review by the FDA for the treatment of chronic idiopathic constipation, and has a PDUFA date (the deadline for when an FDA panel has to make a recommendation on the drug) of January 29, 2017.

Preliminary analysis of the data indicates that both 3 mg and 6 mg doses of plecanatide showed statistical significance in the percentage of patients who were overall responders compared to placebo during the 12-week study.

“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.

Synergy's Chief Strategy Officer Marino Garcia told Benzinga earlier this month that they felt "very comfortable about plecanatide and the role it can play in the market."

Synergy also reported positive top-line data in the first phase 3 IBS-C trial with plecanatide earlier this month.

The stock traded at $4.98, up 5 percent in the after-hours session after closing at $4.74.