Lexicon Pharmaceuticals Inc. announced that the company's investigational new drug, LX1031, a tryptophan hydroxylase inhibitor, demonstrated positive results in clinically important parameters for the treatment of non-constipating irritable bowel syndrome. 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. 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 dose, each administered four times daily. LX1031 was well tolerated, with no statistically significant differences in adverse events observed between placebo and either treatment group.

To discuss top-line results of LX1031, a tryptophan hydroxylase inhibitor

To discuss the LX1031 results