NOTE: this story has been updated with the Furiex stock price at market close Thursday.
Positive trial results for a medication to treat irritable bowel syndrome sent stock prices significantly higher this week for Furiex Pharmaceuticals, a drug development company founded and chaired by Fred Eshelman.
Eshelman also founded Wilmington-based PPD and maintains an office in the Wells Fargo building in downtown Wilmington from where he oversees Furiex’s operations.
In its announcement Tuesday, the company stated that two pivotal Phase III clinical trials evaluating the efficacy and safety of the new drug eluxadoline in treating diarrhea-predominant irritable bowel syndrome (IBS-d) met targets set by both the U.S. Food and Drug Administration and the European Medicines Agency for alleviation of two key symptoms of the disease.
Furiex shares shot up 145 percent at the news, closing at $105.69 on Tuesday – Furiex’s highest price since the stock began trading in June 2010. At market close on Thursday, the price per share was $109.73.
In a telephone interview Thursday, Eshelman discussed his assessment of the drug’s market potential.
“We view the commercial possibilities here to be substantial,” he said. “There are three reasons for this: a) IBS-d is a very prevalent syndrome in the U.S. and Europe; b) it can be very debilitating for people who have it; and c) there is an unmet medical need [for the drug] in that only one other drug is approved for use in the U.S., it only works for women, and its approved use is restricted because of safety concerns.”
Furiex began as the compound partnering segment of PPD, which Eshelman founded in 1985 as a one-person consulting firm and grew into one of the largest contract research organizations in the industry.
In June 2010, he spun off the compound partnering segment as a separate business entity. While Furiex is officially headquartered in Morrisville, N.C., Eshelman said that his company is “very virtual” with many employees working from their homes in scattered locations.
While specific numbers of IBS-d sufferers are unavailable, it is estimated that 15 percent of the U.S. population – or 45 million people – have IBS, which is classified into three types. One type is IBS-d, which is characterized by diarrhea and probably affects a third of all sufferers. Add those 15 million individuals to the estimated 13 million IBS-d patients in Europe, and there is a potential market of about 28 million people, Eshelman said.
In a news release earlier this week Eshelman said he was “pleased with the strength of the data, and proud of our team for its hard work and excellent development of eluxadoline.”
“In just under four years, working closely with regulatory authorities, the team has completed nine Phase I studies, a Phase II dose-ranging trial in approximately 800 patients, and these two large Phase III trials,” he said in the release. “Additionally, we have completed all toxicology studies and believe we are on schedule, including chemistry and manufacturing work, for an NDA [new drug application] submission [to the FDA] by the end of the second quarter of 2014.”