Lexicon Genetics Files Investigational New Drug Application For LX1031 In Irritable Bowel Syndrome

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Clinical Trials / Drug Trials
Article Date: 06 Dec 2006 - 0:00 PDT

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Lexicon Genetics Incorporated (Nasdaq: LEXG) announced today that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for LX1031, an internally-developed small molecule compound for gastrointestinal disorders such as irritable bowel syndrome. Following FDA review, Lexicon intends to initiate a Phase 1 clinical trial of LX1031 in healthy volunteers 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.

"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 T. Sands, M.D., Ph.D., president and chief executive officer. "LX1031 is the second program from Lexicon's internal target and drug discovery pipeline that has advanced to an initial regulatory filing in 2006. We expect additional Lexicon programs to reach this stage next year."

The target of LX1031 is an intracellular enzyme that is found mainly in the gastrointestinal tract. Lexicon discovered that mice lacking this enzyme have virtually no peripheral serotonin, yet their gastrointestinal function is preserved. Serotonin plays an important role in modulating gastrointestinal function and signals feelings of gastrointestinal discomfort to the brain. LX1031 reduces the serotonin available for receptor activation in the gastrointestinal tract, without affecting serotonin levels in the brain or its central nervous system functions. In human clinical trials, serotonin will serve as an effective biomarker by which to evaluate the activity of LX1031.

Lexicon discovered the target of LX1031 in its Genome5000(TM) program. In this program, Lexicon is analyzing 5,000 genes using its proprietary gene knockout technologies and its extensive physiological and behavioral analyses to discover new drug targets from the human genome. To date, Lexicon has completed the analysis of approximately 3,900 of these genes and has harvested more than 100 promising targets related to major medical needs.

About Lexicon Genetics

Lexicon Genetics is a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease. Lexicon is systematically discovering the physiological and behavioral functions of genes to identify potential points of therapeutic intervention, or drug targets. Lexicon makes these discoveries using its proprietary gene knockout technology to model the physiological effects that could be expected from prospective drugs addressing these targets. For targets that the company believes have high pharmaceutical value, it engages in programs for the discovery and development of small molecule, antibody and protein drugs. Lexicon has advanced knockout-validated targets into drug discovery programs in six therapeutic areas: diabetes and obesity, cardiovascular disease, psychiatric and neurological disorders, cancer, immune system disorders and ophthalmic disease. Lexicon is working both independently and through collaborations and strategic alliances to accelerate the development and commercialization of its discoveries.

Safe Harbor Statement

This press release contains "forward-looking statements," including statements relating to Lexicon's regulatory filings and clinical development program for LX1031 and the potential therapeutic and commercial potential of LX1031 and other potential drug candidates in Lexicon's preclinical pipeline. This press release also contains forward-looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon's ability to successfully conduct clinical development of LX1031 and preclinical development of other potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Factors Affecting Forward-Looking Statements" and "Business - Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2005, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

Lexicon Genetics Incorporated
http://www.lexicon-genetics.com