Lexicon
Genetics Incorporated (Nasdaq: LEXG) 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
lexicon-genetics.
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
lexicon-genetics
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