Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today announced completion of patient enrollment in the company’s two ongoing Phase III clinical trials studying eluxadoline for the treatment of diarrhea-predominant irritable bowel syndrome, or IBS-d. Both studies met their target enrollments and Furiex expects to release top line results in the first quarter of 2014.
The two Phase III trials have the same overall design and efficacy endpoints, but differ in overall duration. One study has a 52-week treatment period and the other a 30-week treatment period. Each study has three treatment arms, placebo, 75 mg eluxadoline twice a day and 100 mg eluxadoline twice a day, with approximately 375 patients per arm, and is designed to capture both the U.S. Food and Drug Administration and the European Medicines Agency endpoints for treatment of IBS-d.
“Final completion of enrollment in the Phase III clinical trials for eluxadoline brings us one step closer to our goal of submitting a New Drug Application,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex, “We believe there is an unmet need for IBS-d treatment that has efficacy in both pain and diarrhea, with good tolerability and a convenient dosing schedule.”
Eluxadoline is a first-in-class, locally-acting mu opioid receptor agonist and delta opioid receptor antagonist in Phase III development for treatment of IBS-d.
studies indicate that the activity of eluxadoline at the two different opioid receptors controls GI function as well as decreases pain and potentially mitigates the constipating effect of unopposed mu agonism. Eluxadoline is locally active in the gut with very limited systemic bioavailability, thus potentially decreasing central nervous system effects and other systemic side effects associated with therapies currently used to manage IBS-d.
Diarrhea-predominant irritable bowel syndrome is a functional bowel disorder characterized by chronic abdominal pain and frequent diarrhea, which affects approximately 12 million Americans. Although the exact cause of IBS-d is not known, symptoms are thought to result from a disturbance in the way the gut and nervous system interact. IBS-d can be extremely debilitating and there are limited therapeutic options for managing the chronic symptoms. IBS-d is associated with economic burden in direct medical costs and indirect social costs such as absenteeism and lost productivity, along with decreased quality of life.