THE WOODLANDS, Texas, April 24 /PRNewswire-FirstCall/ -- Following positive results from a Phase 1a study, Lexicon Genetics Incorporated has initiated a Phase 1b clinical trial of its investigational new drug LX1031 for irritable bowel syndrome. LX1031 was found to be well-tolerated at all doses tested in the recently completed Phase 1a randomized, double-blind, ascending single-dose clinical trial.
"The safety and pharmacokinetic profile exhibited by LX1031 in the initial Phase 1a trial is consistent with our observations in preclinical studies," said Philip M. Brown, M.D., J.D., vice president of clinical development at Lexicon. "IBS is a widespread medical condition, affecting as many as one in five(1) Americans, many of whom are not receiving adequate relief from lifestyle changes or available medications. We believe LX1031 has potential to be an important drug in the management of this largely unmet medical need."
The Phase 1b trial is a randomized, double-blind, ascending multiple-dose study designed to evaluate safety and tolerability of LX1031 after multiple doses in approximately 40 healthy volunteers. Lexicon expects data from this clinical trial in the third quarter of 2007.
LX1031 is an oral drug candidate for IBS 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 (GI) 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 GI tract. 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 most commonly characterized by cramping, abdominal pain, bloating, constipation or diarrhea. Symptoms of IBS are believed to be mediated through serotonin, a neurotransmitter that is produced primarily in the GI tract which has been shown to play an important role in modulating motility and signals feelings of GI discomfort to the brain. Some people can control their symptoms with diet and stress management; however, for many, medication is required since IBS can become disabling and result in an inability to work, attend social events or even travel short distances.
Lexicon is a biopharmaceutical company focused on the discovery and development of breakthrough treatments for human disease. Lexicon currently has clinical programs underway for such areas of major unmet medical need as irritable bowel syndrome and cognitive disorders. The company has used its proprietary gene knockout technology to discover more than 100 promising drug targets and create an extensive pipeline of clinical and preclinical programs in the therapeutic areas of diabetes and obesity, cardiovascular disease, psychiatric and neurological disorders, cancer, immune system disorders and ophthalmic disease. To advance the development and commercialization of its programs, Lexicon is working both independently and through collaborators including Bristol-Myers Squibb Company, Genentech, Inc., N.V. Organon and Takeda Pharmaceutical Company Limited. For additional information about Lexicon and its programs, please visit 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 "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2006, 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.
(1) National Digestive Diseases Information Clearinghouse, a service of
the National Institute of Diabetes and Digestive and Kidney Diseases,
National Institutes of Health.
Lexicon Genetics Incorporated