Following FDA review, Lexicon intends to initiate a phase I clinical trial of LX1031 to assess the compound's safety, tolerability and pharmacokinetics. In preclinical studies, LX1031 has demonstrated the ability to reduce peripheral serotonin, a neurotransmitter that is known to play a major role in gastrointestinal function.
LX1031 works locally in the gastrointestinal tract with little systemic exposure and has exhibited an excellent safety profile in preclinical studies. In human clinical trials, serotonin will serve as an effective biomarker by which to evaluate the activity of LX1031.
“We believe that LX1031, which operates through a new mechanism of action, may offer an attractive therapeutic alternative for millions of patients with irritable bowel syndrome and other gastrointestinal disorders who currently have limited treatment options,” said Arthur Sands, president and CEO.