Lexicon initiates Ph II IBS trial for LX1031

The USA's Lexicon Pharmaceuticals has initiated a Phase II trial of LX1031, its oral drug candidate for the treatment of irritable bowel  syndrome.

The trial, which began at the end of last year, is a four-week,  randomized, double-blind, placebo-controlled study to evaluate the  safety and tolerability of LX1031 and its effects on symptoms associated  with IBS. The study will include 150 patients with either  diarrhea-predominant IBS or mixed IBS. Two dose levels will be  evaluated: 250mg and 1,000mg, 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.

"Patients with IBS have limited treatment options and are in need of  safer, more effective therapies," said Philip Brown, senior vice  president of clinical development. "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," he added.