“LX1031 may provide a useful treatment alternative for the management of patients suffering with IBS who are not well managed with existing therapies,” said Philip Brown, vice president of clinical development at Lexicon.
“Given its novel mechanism and excellent tolerability profile in preclinical studies, we believe LX1031 may also have utility in gastrointestinal disorders beyond IBS.”
The phase I trial of LX1031 is a single dose study that will evaluate its safety, tolerability and pharmacokinetics in approximately 40 normal healthy volunteers. This trial is expected to be followed by a multiple dose study of similar size. Lexicon expects results from both of these trials in 2007.
In preclinical studies, LX1031 showed a dose-dependent reduction of serotonin levels in the gastrointestinal tract of multiple species. In human clinical trials, Lexicon intends to use serotonin as a biomarker by which to evaluate the activity of LX1031.