Synergy Posts Topline Phase 2 Data For OIC Drug

Synergy Pharmaceuticals reported positive data from its Phase 2 trial investigating SP-333 in patients with opioid-induced constipation (OIC).

SP-333 is a next-generation uroguanylin analog undergoing development for OIC and mild-to-moderate ulcerative colitis. The drug is a potent and stable version of the naturally occurring gastrointestinal (GI) hormone uroguanylin. SP-333 is resistant to proteolysis in gastric intestinal fluids and is designed to mimic the natural hormone’s activity to target different GI conditions.

The double blind, randomized Phase 2 trial evaluated the safety, efficacy, and dose response of three different doses of once-daily oral SP-333 tablets against placebo in 289 patients with OIC who took opioid analgesics for chronic, non-cancer pain for at least 3 months. Preliminary analysis of results show that the drug was well tolerated and had a favorable safety profile at all doses. The drug also met the trial’s primary endpoint and significantly improved the number of spontaneous bowel movements (SBMs) at the fourth week of treatment period.

Dr. Gary S. Jacob, Chairman and CEO of Synergy Pharmaceuticals, said, “SP-333 is the first and only GC-C agonist to demonstrate efficacy in treating OIC patients. Synergy now has a clinically validated platform technology consisting of two very unique GC-C agonists – plecanatide and SP-333 – both analogs of the natural GC-C agonist, uroguanylin, with proven efficacy and excellent tolerability for treating a variety of gastrointestinal conditions.” Dr. Jacob added that the company will reveal the complete dataset in the next few weeks and will present additional results at a future scientific meeting.

Synergy recently reported similar positive results from the Phase 2B study of plecanatide in irritable bowel syndrome with constipation.

Aside from Synergy, other pharmaceutical companies that are developing treatments for OIC include the British drug maker AstraZeneca. AZ’s Moventig for OIC received the backing of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in September this year.