Synergy Pharmaceuticals (SGYP) have unveiled plans to start a Phase II trial of SP-333, the company’s proprietary next-generation guanylate cyclase-C (GC-C) agonist, for the treatment of opioid-induced constipation (OIC).
The trial is designed as a dose-ranging study to assess a four-week regimen of SP-333, a once daily oral treatment, in adult patients taking opioid analgesics for chronic, non-cancer pain for at least three months.
According to the company, the only oral drug currently FDA approved to treat OIC in patients with chronic, non-cancer pain needs multiple daily dosing and it is not effective against methadone-related OIC.
Synergy Pharmaceuticals president and chief executive officer Gary Jacob said the start of the trial represents the ongoing progress being made in the clinical development of our novel GC-C agonist platform in multiple gastrointestinal indications.
"We recognise a significant market opportunity for new OIC drug candidates and believe SP-333 has excellent potential to address the unmet medical needs of these patients," Jacob said.
"We look forward to evaluating the potential role of SP-333 for OIC as part of our continuing commitment to deliver value to our shareholders and improve patient care."
The pre-clinical data on SP-333 in an animal model of OIC will be released at the American College of Gastroenterology (ACG) 2013 Annual Scientific Meeting to be held between 11-16 October in San Diego, California, US.
SP-333, which is in clinical development to treat OIC and inflammatory bowel disease, has completed a Phase I study in healthy volunteers and is now poised to enter Phase II trials for OIC in the fourth quarter of 2013.
In addition, the company plans to initiate the Phase III registration trial for plecanatide in chronic idiopathic constipation (CIC) in the fourth quarter of this year.
Plecanatide, a synthetic analog of the human GI hormone, uroguanylin, is currently under development for the treatment of CIC and irritable bowel syndrome with constipation (IBS-C).
Synergy focuses on the development of new drugs to treat patients with gastrointestinal (GI) diseases and disorders, its lead proprietary drug candidate ‘plecanatide’ is a synthetic analog of the human GI hormone, uroguanylin and functions by activating the guanylate cyclase-C (GC-C) receptor on epithelial cells of the GI tract.