US drug developer Lexicon Pharmaceuticals (Nasdaq: LXRX) saw its shares leap 9.1% to $2.04 in premarket trading yesterday, as the company announced that the Food and Drug Administration has fast-tracked in its LX1033, an orally-delivered small molecule drug candidate for diarrhea-predominant irritable bowel syndrome (IBS-d).
LX1033, an inhibitor of tryptophan hydroxylase (TPH) that acts locally in the gastrointestinal tract, is currently being evaluated in a Phase II clinical trial for IBS-d. The Phase II trial is a randomized, double-blind study designed to evaluate the safety and efficacy of LX1033 versus placebo in around 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 II trial for IBS-d.
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