Lexicon Pharmaceuticals - Clinical Pipeline - LX1031 For Irritable Bowel Syndrome (IBS)

LX1031 For Irritable Bowel Syndrome (IBS)

LX1031 is an orally-delivered small molecule under development for the potential treatment of irritable bowel syndrome (IBS) and other gastrointestinal disorders. Data from a Phase 2 clinical trial evaluating the safety and tolerability of LX1031 and its effects on symptoms associated with IBS showed that treatment with 1,000 mg of LX1031 four times daily was well tolerated and produced a statistically significant improvement in the global assessment of relief of IBS pain and discomfort over the four-week treatment period compared to placebo. Improvements in the global assessment of adequate relief corresponded with statistically significant improvements in stool consistency in the same dose group. Increased clinical response correlated with a greater reduction in serotonin synthesis as reflected by measures of urinary 5-HIAA, the primary metabolite of serotonin and a biomarker for serotonin production. In Phase 1 clinical trials, all dose levels were well tolerated, no dose-limiting toxicities were observed, and LX1031 was shown to reduce levels of urinary 5-HIAA. LX1031 was designed to inhibit tryptophan hydroxylase, or TPH, the rate-limiting enzyme for serotonin production found primarily in enterochromaffin, or EC, cells of the gastrointestinal tract.