Profile: Synergy Pharmaceuticals Inc (SGYP.O)
8 Dec 2016
Synergy Pharmaceuticals Inc. (Synergy), incorporated on February 11, 1992, is a biopharmaceutical company focused on the development and commercialization of gastrointestinal (GI) therapies. The Company's GI platform includes two lead product candidates: plecanatide and dolcanatide. It is engaged in the discovery, research and development involving uroguanylin analogs for the treatment of functional GI disorders and inflammatory bowel disease.
Plecanatide is the Company's uroguanylin analog being evaluated for use as a once-daily tablet for two functional GI disorders, chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Plecanatide is a 16-amino acid peptide that is structurally identical to uroguanylin with the exception of a single amino acid change. Plecanatide is designed to mimic the function of uroguanylin by working locally in the upper GI tract to stimulate digestive fluid movement and support regular bowel function. The plecanatide phase III CIC program includes two randomized, 12-week, double-blind, placebo-controlled pivotal trials evaluating the efficacy and safety of two different plecanatide treatment doses (3.0 milligrams and 6.0 milligrams), taken as a tablet once-a-day, in patients with CIC. Both trials include an approximately two-week pre-treatment baseline period, a 12-week treatment period, and a two-week post-treatment period. The plecanatide Phase III IBS-C program includes two randomized, 12-week, double-blind, placebo-controlled pivotal trials evaluating the efficacy and safety of two different plecanatide treatment doses (3.0 milligrams and 6.0 milligrams), taken as a tablet once-a-day, in patients with IBS-C.
Dolcanatide is also its uroguanylin analog being explored for inflammatory bowel disease (IBD). Dolcanatide is designed to be an analog of uroguanylin with resistance to standard digestive breakdown by proteases in the intestine. The Company has demonstrated the potential anti-inflammatory role of uroguanylin and uroguanylin analogs in a number of preclinical colitis models. It has released Phase Ib data with dolcanatide in a double-blind, placebo-controlled, four-week study evaluating approximately 30 patients with mild-to-moderate ulcerative colitis.
The Company competes with Ironwood Pharmaceuticals, Inc., Allergan plc, Takeda Pharmaceuticals America, Inc., Sucampo Pharmaceuticals, Inc., AstraZeneca, Valeant Pharmaceuticals International, Inc. and Shire, Plc.
Synergy Pharmaceuticals Inc
420 Lexington Ave Rm 2012
NEW YORK NY 10170-2099
Company Web Links
- BRIEF-Synergy Pharma enters privately-negotiated exchange agreements
- BRIEF-Synergy Pharmaceuticals Inc reports qtrly loss per share of $0.22
- BRIEF-Synergy Pharma files for common stock offering of up to $17.2 million - sec filing
- BRIEF-Synergy Pharmaceuticals announces new plecanatide data presentations
- BRIEF-Synergy Pharma Q2 net loss $38.6 million