Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced today that results from the Phase 2 clinical trial of LX1031 in patients with non-constipating irritable bowel syndrome (IBS) were published earlier this week in the August 2011 edition of the journal Gastroenterology. The issue also included an expert editorial discussing the study, its implications and the potential utility of this mechanism of action in gastrointestinal disease.
Results of the Phase 2 study showed that the tryptophan hydroxylase inhibitor, LX1031, was well tolerated and provided clinical benefit to patients with non-constipating IBS, showing improvements in a global assessment of adequate relief from IBS pain and discomfort and in stool consistency. Notably, symptom relief correlated with reduced levels of 5-HIAA, a biomarker of serotonin production.
Lexicon recently completed a Phase 1 study of LX1033, a follow-on compound that is significantly more potent than LX1031. In the study, LX1033 produced reductions in the 5-HIAA biomarker in healthy volunteers comparable to those seen with LX1031, but with lower and less frequent dosing. Lexicon intends to advance LX1033 into a Phase 2 clinical trial as its lead drug candidate in IBS.