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Lexicon Announces Positive Phase 2 Results of LX1031 in Non-Constipating Irritable Bowel Syndrome
Date:11/12/2009

THE WOODLANDS, Texas, Nov. 12 /PRNewswire-FirstCall/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that the company's investigational new drug, LX1031, a tryptophan hydroxylase (TPH) inhibitor, demonstrated positive results in clinically important parameters for the treatment of non-constipating irritable bowel syndrome (IBS). Top-line results showed that treatment with one gram of LX1031 four times daily produced a statistically significant improvement in global assessment of relief of IBS pain and discomfort over the four-week dosing period as compared to placebo (p=0.0465). Improvements in global assessment parameters also corresponded with statistically significant improvements in stool consistency. Notably, increased clinical response correlated with a greater reduction in serotonin synthesis as reflected by measures of urinary 5-HIAA, a breakdown product of serotonin.

"Treatment with LX1031 reduced symptoms of IBS in this clinical trial, and holds promise for patients with this disease," said Dr. Brian Zambrowicz, chief scientific officer at Lexicon. "We believe the fact that the clinical benefit was correlated to the reduction in the 5-HIAA biomarker validates our therapeutic strategy of inhibiting TPH as a novel treatment option for patients with IBS. The overall safety and efficacy profile observed to date supports further development of this novel mechanism in IBS."

The Phase 2 clinical trial, which began at the end of December 2008, was a four-week, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LX1031 and its effects on symptoms associated with IBS. The study included 155 patients with either diarrhea-predominant IBS or mixed IBS. Two dose levels were evaluated: a 250 mg dose and a 1,000 mg
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SOURCE Lexicon Pharmaceuticals, Inc.
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