Lexicon Advances LX1031 for Irritable Bowel Syndrome Into Phase 1b Clinical Trial
THE WOODLANDS, Texas, April 24 /PRNewswire-FirstCall/ -- Following positive results from a Phase 1a study, Lexicon Genetics Incorporated (Nasdaq: LEXG - News) has initiated a Phase 1b clinical trial of its investigational new drug LX1031 for irritable bowel syndrome. LX1031 was found to be well-tolerated at all doses tested in the recently completed Phase 1a randomized, double-blind, ascending single-dose clinical trial.
"The safety and pharmacokinetic profile exhibited by LX1031 in the initial Phase 1a trial is consistent with our observations in preclinical studies," said Philip M. Brown, M.D., J.D., vice president of clinical development at Lexicon. "IBS is a widespread medical condition, affecting as many as one in five(1) Americans, many of whom are not receiving adequate relief from lifestyle changes or available medications. We believe LX1031 has potential to be an important drug in the management of this largely unmet medical need."
The Phase 1b trial is a randomized, double-blind, ascending multiple-dose study designed to evaluate safety and tolerability of LX1031 after multiple doses in approximately 40 healthy volunteers. Lexicon expects data from this clinical trial in the third quarter of 2007.
About LX1031
LX1031 is an oral drug candidate for IBS and other gastrointestinal disorders. LX1031 was generated by Lexicon medicinal chemists, and its target was internally identified as a key control point for the regulation of peripheral serotonin levels. LX1031 is designed to act locally in the gastrointestinal (GI) tract by reducing the serotonin available for receptor activation, without affecting serotonin levels in the brain or its central nervous system functions. In preclinical studies, LX1031 showed a dose-dependent reduction of serotonin levels in the GI tract. In human clinical trials, Lexicon intends to use serotonin as a biomarker by which to evaluate the activity of LX1031.
The target of LX1031 is an enzyme that is found predominantly in the gastrointestinal tract. Lexicon discovered that mice lacking this enzyme have virtually no peripheral serotonin but normal levels of brain serotonin. No adverse effects were observed in these animals across a broad range of medically-relevant parameters, suggesting a favorable safety profile for the mechanism of action of this drug target. |
