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.”
About Eluxadoline
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.
About 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.
About Furiex
Furiex Pharmaceuticals is a drug development collaboration company that uses innovative clinical development design to accelerate and increase value of drug development programs by advancing them through the drug discovery and development process in a cost-efficient manner. Our drug development programs are designed and driven by a core team with extensive drug development experience. The company collaborates with pharmaceutical and biotechnology companies and has a diversified product portfolio and pipeline with multiple therapeutic candidates, including one Phase III-ready asset, two compounds in Phase III development, one of which is with a partner, and four products on the market. The company’s mission is to develop innovative medicines faster and at a lower cost, thereby improving profitability and accelerating time to market while providing life-improving therapies for patients. For more information, visit www.furiex.com.
Except for historical information, all of the statements, expectations and assumptions contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although Furiex attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. In addition, other important factors which could cause actual results to differ materially include the following: the inability to show sufficient efficacy and safety of eluxadoline; successful submission, review and approval of a new drug application by the U.S. Food and Drug Administration (FDA) and a marketing authorization application by the European Medicines Agency (EMA) for eluxadoline; decisions by regulatory agencies, such as the FDA, EMA and Drug Enforcement Agency, regarding labeling, scheduling and other matters that could affect the availability or commercial potential of eluxadoline; potential changes to regulatory guidance applicable to approval of irritable bowel syndrome drugs; future clinical data and analysis, including post marketing; the need to find collaborators to help develop and commercialize eluxadoline; continuing losses and our potential need for additional financing; and the other risk factors set forth from time to time in the SEC filings for Furiex, copies of which can be found on our website.
Furiex Pharmaceuticals, Inc.
Media/Analysts/Investors:
Sailash Patel, 919-456-7814
sailash.patel@furiex.com