Lexicon initiates Phase II irritable bowel syndrome trial

The Phase II clinical trial, which began at the end of December 2008, is designed as a four-week, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LX1031 and its effects on symptoms associated with irritable bowel syndrome (IBS).

The study will include 150 patients with either diarrhea-predominant IBS or mixed IBS. Two dose levels will be evaluated: a 250mg dose and a 1,000mg dose, each administered four times daily. The endpoints will include assessments of the effects of LX1031 on specific symptoms associated with IBS, as well as a global assessment of adequate relief.

Lexicon has three additional drug candidates progressing through various stages of clinical development, including LX1032 for carcinoid syndrome, LX2931 for rheumatoid arthritis, and LX4211 for diabetes. LX1031 is being developed in a product development collaboration with Symphony Capital Partners and its co-investors.

Philip Brown, senior vice president of clinical development at Lexicon, said: Patients with IBS have limited treatment options and are in need of safer, more effective therapies. LX1031 is intended to treat symptoms associated with IBS, including diarrhea and abdominal discomfort, by operating through an important new mechanism to reduce serotonin levels locally in the gastrointestinal tract.