Lexicon Pharmaceuticals, Inc. Drug Candidate for Cognitive Disorders Successfully Completes Phase 1 Clinical Trial
THE WOODLANDS, Texas, July 31 /PRNewswire-FirstCall/ -- Lexicon Pharmaceuticals, Inc. today announced that LX6171, an oral drug candidate for cognitive disorders, successfully completed Phase 1 clinical trials. LX6171 was well-tolerated at all dose levels and showed excellent systemic exposure. Over the seven day trial, no dose-limiting toxicities were observed and exposure levels supported a once daily dosing regimen. LX6171 is being developed under a product development collaboration with Symphony Capital Partners, L.P. and its co-investors ("Symphony").
"The safety and exposure profile of LX6171 that was observed in Phase 1 encourages us to proceed with further development," commented Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Lexicon Pharmaceuticals. "We look forward to progressing LX6171 into Phase 2 clinical trials."
The recently completed Phase 1b study of LX6171 was designed as a randomized, double-blind, placebo-controlled, multiple ascending-dose study to evaluate safety, tolerability and pharmacokinetics over seven days of dosing in normal healthy young (age 18-50) and elderly (age 65-80) volunteers. Lexicon expects to receive full audited results of its Phase 1 trials in the third quarter of 2007 and anticipates filing with European regulatory authorities for approval of its Phase 2 plans in the fourth quarter. Pending regulatory approval, Lexicon plans to initiate Phase 2 clinical trials in the first quarter of 2008.
LX6171 is an oral drug candidate that was generated by Lexicon's small molecule drug discovery team and is being developed to treat disorders characterized by cognitive impairment, such as Alzheimer's disease, schizophrenia or vascular dementia. Its target, a membrane protein that is expressed exclusively in the central nervous system, was identified through Lexicon's Genome 5000(TM) program through the study of mouse knockouts that showed enhanced learning and memory. LX6171 is a potent oral inhibitor of its target and reproduces these effects in animal models.
About Symphony Icon
Lexicon entered into a product development collaboration with Symphony in June 2007. Under the terms of the arrangement, $45 million was provided to Symphony Icon, Inc., a newly-created company established to fund and accelerate development of Lexicon's first three product candidates and hold the license to the intellectual property of LX6171, LX1031 and LX1032. An additional $15 million of equity capital was provided directly to Lexicon for general corporate purposes.
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. and N.V. Organon. For additional information about Lexicon and its programs, please visit www.lexpharma.com.
Lexicon Safe Harbor Statement
This press release contains "forward-looking statements," including statements relating to Lexicon's clinical development of LX6171 and the potential therapeutic and commercial potential of LX6171. 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 LX6171 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.Lexicon Pharmaceuticals, Inc.
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Web site: http://www.lexpharma.com//