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news.Lexicon Pharmaceuticals has successfully completed a Phase I multiple-dose escalation study in normal volunteers with LX1031, its oral drug candidate for irritable bowel syndrome.
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The Phase I trial was a randomized, double-blind, ascending multiple-dose study in which all dose levels were well tolerated over 14 days and no dose limiting toxicities were observed. LX1031 is designed to treat symptoms associated with irritable bowel syndrome (IBS) by decreasing the production of serotonin in the gastrointestinal tract. Serotonin is a key regulator of gastrointestinal sensation and motility.
Importantly, the study showed that LX1031 decreased urinary 5-hydroxyindoleacetic acid (5-HIAA), a metabolite of serotonin and biomarker for serotonin production, at all dose levels tested as compared to the placebo group.
These results are consistent with a significant reduction in gastrointestinal serotonin synthesis. Doses tested in this study were 250mg, 500mg, 750mg, and 1,000mg, each administered four times daily. Data from this study will be utilized to select a dosing regime for the Phase II proof-of-concept clinical trial.
Based on the successful outcome of this Phase I study, Lexicon expects to initiate a Phase II proof-of-concept clinical trial in IBS patients in the fourth quarter of this year.
This clinical trial is planned as a four-week, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and effects of LX1031 on symptoms associated with IBS.