Synergy Pharmaceuticals Inc., a biopharmaceutical company focused on the development of new drugs to treat patients with gastrointestinal diseases and disorders, has announced plans to move forward this quarter with SP-333, its proprietary next-generation guanylate cyclase-C (GC-C) agonist, into a phase 2 study for the treatment of opioid-induced constipation (OIC).
“The start of this trial represents the ongoing progress being made in the clinical development of our novel GC-C agonist platform in multiple gastrointestinal indications,” said Dr. Gary S Jacob, president and chief executive officer of Synergy Pharmaceuticals Inc. “We recognize 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. 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 phase 2 trial is designed as a dose-ranging study to evaluate a 4-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. The only oral drug currently FDA approved to treat OIC in patients with chronic, non-cancer pain requires multiple daily dosing and it is not effective against methadone-related OIC.
Pre-clinical data on SP-333 in an animal model of OIC will be featured in a poster presentation at the American College of Gastroenterology (ACG) 2013 Annual Scientific Meeting being held October 11-16 in San Diego, California.