Lexicon Pharmaceuticals, Inc. Reports Initial Clinical Trial Results for LX1031, an Investigational New Drug for Irritable Bowel Syndrome
PHILADELPHIA and THE WOODLANDS, Texas, Oct. 15 /PRNewswire-FirstCall/ -- Lexicon Pharmaceuticals, Inc. presented data regarding Phase 1 clinical trial results for LX1031 at the annual meeting of the American College of Gastroenterology in Philadelphia, Pennsylvania. The studies demonstrated that LX1031 was generally well-tolerated at all dose levels and that exposure levels in blood were low. A statistically significant reduction of urinary 5-hydroxyindoleacetic acid (5-HIAA), a metabolite of serotonin and biomarker for serotonin production, was observed in subjects who received the highest dose tested, 2,000 mg per day, for two weeks. Over the fourteen-day trial, no dose-limiting toxicities were observed.
LX1031 was developed as an orally-administered potential treatment for irritable bowel syndrome (IBS) and other gastrointestinal (GI) disorders. Preclinical studies demonstrated that LX1031 lowers serotonin levels in the intestine without affecting levels in the brain.
"We are pleased with the results of our initial human studies of LX1031," said Philip M. Brown, M.D., J.D., Lexicon's vice president of clinical development. "The compound was well tolerated, consistent with our preclinical observations, and we are encouraged by the 5-HIAA biomarker results. We look forward to progressing LX1031 into Phase 2 clinical trials in 2008."
About LX1031 and Irritable Bowel Syndrome
Based on findings from Lexicon's proprietary knock-out mouse technology, LX1031 was developed by Lexicon's small molecule drug discovery team as an orally-administered inhibitor of tryptophan hydroxylase, a key enzyme in the synthesis of serotonin.
Serotonin is a neurotransmitter found primarily in the brain and GI tract, where it has distinctly different functions. In the brain, serotonin is associated with mood and behavior, whereas in the GI tract it stimulates motility and signals feelings of discomfort and nausea. The dysregulation of serotonin is thought to be associated with functional GI disorders, including IBS.
IBS is a functional bowel disorder of the GI tract characterized by changes in bowel habits that are not specifically associated with any particular disease. Symptoms include diarrhea, constipation, bloating, gas, abdominal pain, and cramping. As many as one in five American adults suffers from IBS, making it the most common disorder seen by gastroenterologists and one of the most common disorders seen by primary care physicians.
LX1031 is being developed in a product development collaboration with Symphony Capital Partners, L.P. and its co-investors.
Lexicon is a biopharmaceutical company focused on the discovery and development of breakthrough treatments for human disease. Lexicon currently has development 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. and N.V. Organon. For additional information about Lexicon and its programs, please visit http://www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements," including statements relating to Lexicon's clinical development of LX1031 and the potential therapeutic and commercial potential of LX1031. 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 and clinical development of its 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.
CONTACT: Chas Schultz, Director of Financial Analysis of Lexicon
Pharmaceuticals, Inc., +1-281-863-3421, firstname.lastname@example.org
Web site: http://www.lexpharma.com/