THE WOODLANDS, Texas, Jan. 30 /PRNewswire-FirstCall/ -- Lexicon Genetics Incorporated announced today that it has initiated a Phase 1b clinical trial of LX6171, its oral drug candidate for the treatment of cognitive impairment associated with disorders such as Alzheimer’s disease, schizophrenia and vascular dementia. These disorders affect millions of people worldwide, and their prevalence is increasing as the population ages.
“LX6171 was well tolerated at all dose levels studied and obtained good systemic exposure in its initial Phase 1 trial, a single ascending-dose study completed last year, and we are pleased to advance the compound into this next stage of clinical development,” said Philip M. Brown, M.D., J.D., vice president of clinical development at Lexicon. “This second clinical trial for LX6171, in addition to our recently commenced Phase 1 trial of LX1031 for irritable bowl syndrome, underscores our focus on developing Lexicon’s discoveries into breakthrough treatments for human disease.”
The Phase 1b trial is a randomized, double-blind, placebo-controlled, multiple ascending-dose study to further evaluate LX6171’s safety, tolerability and pharmacokinetics. LX6171 will be studied in approximately 40 normal healthy volunteers, including a cohort of elderly subjects. Lexicon expects results from this trial in mid-2007.
About LX6171
LX6171 is an oral drug candidate that was generated by Lexicon medicinal chemists and is being developed to treat disorders characterized by cognitive impairment, such as Alzheimer’s disease, schizophrenia or vascular dementia. Its target was internally identified as a selective and potent inhibitor of a novel membrane protein that is expressed exclusively in the central nervous system. In an initial Phase 1 trial, LX6171 was well tolerated at all dose levels studied, with no clinically significant changes noted. In preclinical studies, LX6171 demonstrated improved learning and memory in healthy and aged animal models.
About Cognitive Disorders
Cognitive disorders such as delirium and dementia produce a significant impairment of cognition and/or memory representing a marked deterioration from a previous level of functioning. Alzheimer’s disease is one of the most well recognized disorders associated with cognitive impairment. Alzheimer’s disease is an irreversible, progressive brain disorder that develops gradually and results in memory loss, behavior and personality changes. Existing therapies that address cognitive impairment in Alzheimer’s patients generally have limited efficacy in early-stage patients, and have side-effect profiles that limit their utility in some patients.
About Lexicon
Lexicon is a biopharmaceutical company discovering and developing 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 which include Genentech, Inc., Bristol-Myers Squibb Company, N.V. Organon and Takeda, Ltd. 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 LX6171 and the potential therapeutic and commercial potential of LX6171 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 LX6171 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 ; or Aline Schimmelof WeissComm Partners, +1-212-301-7218, or schimmel@weisscommpartners.com ,for Lexicon Genetics Incorporated
Web site: http://www.lexicon-genetics.com/
