An irritable bowel syndrome drug from Furiex Pharmaceuticals (Nasdaq:FURX) met key goals in two late-stage clinical trials, results that boosted the stock price of the Morrisville drug developer 129 percent Tuesday morning.
Furiex said the top-line results for the compound eluxadoline met efficacy and safety targets for treating diarrhea-predominant irritable bowel syndrome, or IBS-d. The trial design and the study endpoints for eluxadoline were agreed upon by both the U.S. Food and Drug Administration as well as the European Medicines Agency.
Furiex stock, which had closed Monday at $45.97, reached as high as $121.87 before settling down at $105.54 in mid-morning trading. Furiex finished the trading day at $105.69.
We are pleased with these top-line results, which put us one step closer to filling an unmet medical need in men and women with IBS-d,” Furiex President and Chief Medical Officer June Almenoff, said in a statement. “In addition to showing both rapid onset and durable efficacy of the primary endpoints, both pivotal studies demonstrated robust efficacy for the secondary endpoint of adequate relief of IBS symptoms. We look forward to further analyzing the data and plan to present details at an upcoming medical conference.”
IBS-d patients experience chronic abdominal pain and frequent diarrhea. Furiex said that the condition affects an estimated 28 million patients in the United States and the major markets in Europe. Eluxadoline has been granted Fast Track status by the FDA, a process designed to speed up review of drugs to treat diseases addressing significant unmet medical needs.
Furiex said it plans to submit eluxadoline for regulatory approval in the second quarter.