A statistically significant reduction of urinary 5-hydroxyindoleacetic acid, a metabolite of serotonin and biomarker for serotonin production, was observed in subjects who received the highest dose tested, 2,000mg per day, for 2 weeks. Over the 14 day trial, no dose-limiting toxicities were observed.
Philip Brown, Lexicon’s vice president of clinical development, said: “We are pleased with the results of our initial human studies of LX1031. The compound was well tolerated, consistent with our preclinical observations, and we are encouraged by the 5-hydroxyindoleacetic acid (5-HIAA) biomarker results. We look forward to progressing LX1031 into phase II clinical trials in 2008.”