Lexicon's Completes Phase 2A Trial for AAMI Drug Candidate

THE WOODLANDS, Texas -- Lexicon Pharmaceuticals, Inc. (Nasdaq:LXRX) has completed a Phase 2A clinical trial of LX6171 in a study designed to explore the potential effects of the drug candidate in subjects with age-associated memory impairment (AAMI). Although the compound was well tolerated, there was no clear demonstration of activity for the various cognitive domains evaluated.

"Even though there were isolated instances of activity in the recently-completed Phase 2a study, we believe that the aggregate data do not support further development of LX6171 for cognitive impairment at this time," said Philip M. Brown, M.D., J.D., senior vice president of clinical development at Lexicon. "However, the target of LX6171 continues to be intriguing, as this pathway has recently been associated with schizophrenia in human genetic studies. LX6171, which has demonstrated a favorable safety profile in studies conducted to date, has not been tested in that indication."

"Although we are disappointed with the clinical trial results for LX6171, our portfolio strategy enables us to focus our resources on those programs that are seen to have the greatest opportunity for ultimate success in clinical development," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer at Lexicon. "We will evaluate interest from third parties in the compound and its target for other neurobehavioral indications where the target may be relevant, such as schizophrenia."

In the recently-completed Phase 2a clinical trial, daily doses of LX6171 or placebo were given to 121 healthy elderly subjects with AAMI.

The study evaluated safety, tolerability, and cognitive effects of LX6171 over four weeks. Although LX6171 was well tolerated at all doses evaluated, the trial did not result in significant effects on parameters of attention or memory that would justify further studies in therapeutic indications prioritized by the company.