Lexicon says it will make regulatory filings for advanced programs this year

By Jennifer Lanning Drey

Eugene, Ore., June 14 - Lexicon Genetics Inc. plans to make regulatory filings for its two most advanced programs by the end of the year, according to Dr. Alan J. Main, senior vice president of Lexicon Pharmaceuticals.

Both clinical candidates, LX6171 for Alzheimer's disease and LX1013 for irritable bowel syndrome, were developed through Lexicon's Genome5000 program, which the company is using to discover clinical candidates.

Genome5000 is a one-time study in which Lexicon is working to discover key genes in the human genome that control physiology. The company has studied more than 3,300 genes and developed 90 drug targets since beginning the program, said Main during a presentation at the Needham & Co. Biotechnology and Medical Technology Conference on Wednesday.

"What comes out of this are a small number of very highly validated targets," he said.

LX6171 is a small molecule clinical candidate Lexicon has tested as a treatment for neurological disorders in mice.

"In this test and multiple other assays with different dosing regimes and different timing of dosing, we see consistent activity of LX6171," said Main.

Lexicon will begin studies of the compound in humans once the company makes a decision on the clinical application in which it will test the drug.

Alzheimer's is the most obvious target, but vascular dementia, schizophrenia and attention deficit disorder are also possibilities, he said.

In addition, Lexicon may choose to test LX6171 for fragile X syndrome, which would provide the opportunity to gain orphan drug status, he said.

"Our goal is to gain data in early proof of concept studies in man to help us decide in which direction we're going to take the product," Main said.

Pre-clinical work on LX1013

Lexicon expects to complete pre-clinical studies of its other advanced drug target, LX1013, which is being tested for irritable bowel syndrome, by the end of the year, he said.

The company is currently preparing to perform pre-clinical toxicology studies and beginning to generate the materials needed for the clinical batch of the compound, Main said.

The drug has other possible indications including inflammatory bowel syndrome and Crohn's disease, he added.

Lexicon also expects the Genome5000 program to produce additional drug candidates this year, Main said.

"We have a portfolio of programs, and we're going to put additional clinical candidates in different therapeutic areas into our portfolio this year, which will deliver in 2007," he said.

Lexicon plans to start testing the remaining genes in the Genome5000 program by the end of the year, at which point the program will be 80% complete, he said.

Lexicon Genetics, based in The Woodlands, Texas, is a biopharmaceutical company focused on the discovery and development of breakthrough treatments for human disease. Lexicon focuses on discovering the physiological and behavioral functions of genes to identify potential points of therapeutic intervention or drug targets.

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