Synergy Pharmaceuticals Inc. (Nasdaq:SGYP) today announced the start of a phase 2 clinical trial to evaluate the safety and efficacy of SP-333, its second-generation GC-C agonist and once-daily oral treatment, in adult patients with opioid-induced constipation (OIC).
The multi-center, randomized, double-blind clinical trial will compare a 4-week, dose-ranging regimen of SP-333 (1.0, 3.0 and 6.0mg) against placebo in adult patients taking opioid analgesics for chronic, non-cancer pain for at least three months. The study plans to enroll approximately 260 patients with OIC who have less than 3 spontaneous bowel movements (SBMs) per week and who experience constipation-related symptoms. The primary endpoint of the study is mean change from baseline in the number of SBMs during Week 4 of the Treatment Period.
“Orally administered SP-333 has exhibited compelling data in preclinical models, demonstrating the ability to restore GI transit to normal levels and alleviate the onset of opioid-induced bowel dysfunction,” said Dr. Kunwar Shailubhai, Chief Scientific Officer, Synergy Pharmaceuticals Inc. “We are particularly excited with preclinical data that indicates SP-333 may be effective in treating methadone and morphine related constipation. Clinical validation of efficacy in methadone-induced constipation would be a breakthrough.”
“SP-333 marks Synergy’s second GC-C agonist in clinical development and represents another important milestone achieved this year in advancing our novel GC-C platform,” said Dr. Gary S. Jacob, Chief Executive Officer of Synergy Pharmaceuticals Inc. “Given SP-333’s favorable profile, we believe it has excellent potential to address the unmet needs of OIC patients. Beyond the OIC opportunity, we are continuing to develop a formulation of SP-333 to further explore its anti-inflammatory effect in patients with ulcerative colitis. We believe SP-333 is a very unique GC-C agonist with multiple pathways forward, expanding our ability to reach a broader market of patients in a variety of GI areas.”About Opioid-Induced Constipation Opioid-induced constipation (OIC) is a common condition affecting patients who receive opioid treatments to relieve pain. An estimated 12 million Americans are currently taking chronic opioids and over 90% experience some form of diminished bowel frequency. OIC is characterized by infrequent and incomplete evacuation of stool, hard stool consistency and straining associated with bowel movements. There is only one oral drug approved in the US to treat OIC but it is not approved for use in methadone-induced constipation.