Synergy Pharmaceuticals Inc. (NASDAQ: SGYP)
Synergy is a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies.
We have pioneered discovery, research and development efforts around analogs of uroguanylin, a naturally occurring human GI peptide, for the treatment of GI diseases and disorders. We discovered, are developing and control 100% worldwide rights to our proprietary uroguanylin analog platform that includes two lead product candidates - plecanatide and dolcanatide.
Plecanatide is our first uroguanylin analog currently being evaluated for use as a once-daily tablet for chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Plecanatide is a 16-amino acid peptide that is structurally similar to the body's naturally occurring GI peptide, uroguanylin, with the exception of a single amino acid change. Plecanatide is designed to replicate the activity of uroguanylin by working locally in the upper GI tract to stimulate digestive fluid movement and support regular bowel function. In 2015, we announced positive phase 3 data with plecanatide in two pivotal CIC clinical trials. The plecanatide new drug application (NDA) in CIC is currently under review by the Food and Drug Administration (FDA) and the Prescription Drug User Fee Act (PDUFA) target action date is January 29, 2017. In addition, we are evaluating plecanatide in two phase 3 IBS-C trials and we expect top-line data from both pivotal trials in the fourth quarter of this year. Pending approval in the CIC indication, we plan to file a New Drug Application Supplement with Clinical Data (sNDA) for plecanatide in IBS-C in the first quarter of 2017. Beyond these two indications, we are also evaluating opioid-induced constipation (OIC) as a potential life-cycle growth opportunity for plecanatide.
Dolcanatide is our second uroguanylin analog currently being explored for ulcerative colitis. Dolcanatide is designed to replicate the activity of uroguanylin with enhanced resistance to standard digestive breakdown by proteases in the intestine. In January 2016, we announced positive proof-of-concept with dolcanatide in a phase 1b trial evaluating 28 patients with mild-to-moderate ulcerative colitis. We are planning to meet with regulatory agencies to discuss phase 2 clinical development plans for dolcanatide in mild-to-moderate ulcerative colitis. In November 2014, we reported successful proof-of-concept with dolcanatide in a double-blind, placebo-controlled phase 2 trial in 289 patients with OIC, demonstrating the utility of our uroguanylin analog platform in OIC.