Furiex Pharmaceuticals, Inc., a drug development collaboration company, has completed patient enrollment in its two ongoing phase III clinical trials studying eluxadoline for the treatment of diarrhoea-predominant irritable bowel syndrome (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 US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) 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, MD, 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. In vivo 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.
Diarrhoea-predominant irritable bowel syndrome is a functional bowel disorder characterized by chronic abdominal pain and frequent diarrhea.
Furiex Pharmaceuticals is a drug development collaboration company that uses innovative clinical development design to accelerate and increase value of drug development programmes by advancing them through the drug discovery and development process in a cost-efficient manner.