Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced today that it has received "Fast Track" status from the U.S. Food and Drug Administration (FDA) for the development of LX1033, an orally-delivered small molecule drug candidate for diarrhea-predominant irritable bowel syndrome (IBS-d).
"We are pleased with the FDA's grant of Fast Track status for LX1033 in IBS-d, recognizing this important area of unmet medical need and the potential benefits that LX1033 could provide for those suffering from this disease," said Pablo Lapuerta , M.D., senior vice president and chief medical officer at Lexicon.
LX1033, an inhibitor of tryptophan hydroxylase (TPH) that acts locally in the gastrointestinal tract, is currently being evaluated in a Phase 2 clinical trial for IBS-d. The Phase 2 trial is a randomized, double-blind study designed to evaluate the safety and efficacy of LX1033 versus placebo in approximately 360 IBS-d patients, with results expected in the first half of 2013. LX1033 is a follow-on compound to LX1031, a previous-generation oral, locally-acting TPH inhibitor developed by Lexicon which had previously shown clinical benefit in a Phase 2 trial for IBS-d. Results from the LX1031 Phase 2 trial have been published in the journal Gastroenterology (2011; 141:507-516).
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