THE WOODLANDS, Texas, Jan. 24 /PRNewswire-FirstCall/ -- Lexicon Genetics Incorporated announced today that it has initiated Phase 1 clinical trials of LX1031, its oral drug candidate for irritable bowel syndrome (IBS) and other gastrointestinal disorders. Irritable bowel syndrome is a common gastrointestinal disorder characterized by pain, discomfort and motility problems that affects between 10-20% of adults in the United States.
“LX1031 may provide a useful treatment alternative for the management of patients suffering with IBS who are not well managed with existing therapies,” said Philip M. Brown, M.D., J.D., vice president of clinical development at Lexicon. “Given its novel mechanism and excellent tolerability profile in preclinical studies, we believe LX1031 may also have utility in gastrointestinal disorders beyond IBS.”
The Phase 1 clinical trial of LX1031 is a randomized, double-blind, ascending single dose study that will evaluate LX1031’s safety, tolerability and pharmacokinetics in approximately 40 normal healthy volunteers. This trial is expected to be followed by a randomized, double-blind, ascending multiple dose study of similar size. Lexicon expects results from both of these trials in 2007.
About LX1031
LX1031 is an orally-dosed drug candidate for irritable bowel syndrome and other gastrointestinal disorders. LX1031 was generated by Lexicon medicinal chemists, and its target was internally identified as a key control point for the regulation of peripheral serotonin levels. LX1031 is designed to act locally in the gastrointestinal tract by reducing the serotonin available for receptor activation, without affecting serotonin levels in the brain or its central nervous system functions. In preclinical studies, LX1031 showed a dose-dependent reduction of serotonin levels in the gastrointestinal tract of multiple species. In human clinical trials, Lexicon intends to use serotonin as a biomarker by which to evaluate the activity of LX1031.
The target of LX1031 is an enzyme that is found predominantly in the gastrointestinal tract. Lexicon discovered that mice lacking this enzyme have virtually no peripheral serotonin but normal levels of brain serotonin. No adverse effects were observed in these animals across a broad range of medically-relevant parameters, suggesting a favorable safety profile for the mechanism of action of this drug target.
About Irritable Bowel Syndrome
Irritable bowel syndrome is a disorder characterized most commonly by cramping, abdominal pain, bloating, constipation and diarrhea. Symptoms of IBS are believed to be mediated through serotonin, a neurotransmitter that is produced primarily in the gastrointestinal tract which plays an important role in modulating motility and signals feelings of gastrointestinal discomfort to the brain. Many people can control their symptoms with diet, stress management and prescribed medications. For some people, however, IBS can be disabling and result in an inability to work, attend social events or even travel short distances.
About Lexicon Genetics
Lexicon Genetics is a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease. Lexicon’s lead drug development programs and extensive pipeline of preclinical research programs have resulted from its internal target and drug discovery efforts. Lexicon has used its proprietary gene knockout technology to discover more than 100 promising drug targets addressing major medical needs. Lexicon engages in programs for the discovery and development of small molecule, antibody and protein drugs that modulate the targets in its portfolio. Lexicon is working both independently and through collaborations and strategic alliances to accelerate the development and commercialization of its discoveries. Additional information about Lexicon is available through its corporate website, http://www.lexicon-genetics.com .
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
CONTACT: Bobbie Faulkner, Manager, Investor Relations of Lexicon GeneticsIncorporated, +1-281-863-3503, or bfaulkner@lexgen.com
Web site: http://www.lexicon-genetics.com/
