Shares of Furiex Pharmaceuticals, Inc. (FURX) more than doubled on Feb 4 to close the trading session at $105.69. The massive increase came on the back of encouraging top-line results from two pivotal phase III studies (3001 and 3002) on the company’s candidate eluxadoline for the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-d). The stock also touched a 52-week high of $121.97 during the trading session.
The phase III studies, which evaluated the efficacy and safety of eluxadoline for the treatment of IBS-d, met the primary objectives of composite response on the basis of simultaneous improvements in stool consistency and abdominal pain. The primary objective of the study was as per the U.S. and EU regulatory authorities. The study results showed that responder rates of eluxadoline (100 mg and 75mg) were superior to that of placebo in both the studies at 12 weeks and 26 weeks.
The candidate was also generally safe and well tolerated during both the studies. Encouraged by the positive results, Furiex intends to seek U.S. approval of the candidate in June this year.
As per company sources, around 28 million people in the U.S. and major EU markets are suffering from IBS-d. The company further stated that at present Lotronex is the only approved drug for IBS-d in the U.S. We note that Lotronex is approved exclusively for women and the access of the drug is restricted due to safety related issues. Eluxadoline, on the other hand, was proved to be effective in both men and women in the phase III studies. Meanwhile, there are no approved drugs in the EU for IBS-d.
We are encouraged by the positive results on eluxadoline. On approval, eluxadoline can turn out to be a major growth driver at Furiex as it will serve a market with huge unmet medical need. We expect investor focus to stay on the candidate going forward.
Furiex currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Salix Pharmaceuticals Ltd. (SLXP), Affymetrix Inc. (AFFX) and Actelion Ltd. (ALIOF). All the stocks hold a Zacks Rank #1 (Strong Buy).