Lexicon Initiates Phase 2a Trial of LX6171 Drug Candidate for Cognitive Disorders
December 05 2007 - 6:30AM
PR Newswire (US)
THE WOODLANDS, Texas, Dec. 5 /PRNewswire-FirstCall/ -- Lexicon
Pharmaceuticals, Inc. (NASDAQ:LXRX) announced today that dosing has
commenced in a Phase 2a clinical trial with LX6171, an oral drug
candidate for the treatment of cognitive impairment associated with
disorders such as Alzheimer's disease, schizophrenia, and vascular
dementia. The initial stage of the trial will assess the
bioavailability of a new oral-suspension formulation in healthy
elderly subjects with a second stage evaluating safety,
tolerability and cognitive effects in elderly subjects with
age-associated memory impairment (AAMI). "AAMI is an emerging area
of clinical research and offers an expedient population for
obtaining proof-of-concept with a drug candidate, like LX6171, that
has a broad range of potential applications in the area of
cognitive disorders," said Philip M. Brown, M.D., J.D., vice
president of clinical development at Lexicon. "Following the
strength of the Phase 1 data indicating LX6171 is generally well
tolerated, we have adopted a two-stage strategy for Phase 2a in
order to transition to our new oral suspension formulation and to
assess for improvements in a variety of cognitive dimensions as we
enter the elderly population." Phase 2 Study Design The initial
stage of the trial will assess the bioavailability of a single-dose
oral suspension in 16 healthy elderly subjects. The second stage
will be a randomized, double-blind, placebo-controlled evaluation
of safety, tolerability, and cognitive effects in approximately 120
subjects over four weeks. This stage is anticipated to include
three groups of 40 subjects each, exploring two dose levels with a
placebo control. Exact dose levels for the second stage will be set
based on evaluation from the first stage pharmacokinetic study
using the new formulation. The second stage will evaluate the
safety and tolerability of LX6171 oral suspension in subjects
exhibiting AAMI and will measure the cognitive effects of LX6171 in
these subjects using the Cognitive Drug Research battery, along
with other psychometric instruments. The study is being conducted
in Europe, with initial results expected by the end of 2008. About
LX6171 LX6171 is an orally-bioavailable small molecule developed by
Lexicon scientists to inhibit a membrane protein expressed
exclusively in the central nervous system and found at synaptic
vesicles and presynaptic membranes of glutamatergic neurons. The
protein targeted by LX6171 was identified through Lexicon's
large-scale gene knockout program, the Genome5000(TM). Knockout
mice lacking this protein showed improved learning and memory
compared with controls. In preclinical studies, administration of
LX6171 resulted in improved performance in tests of learning and
memory in mice. In Phase 1 clinical trials, LX6171 was generally
well tolerated at all dose levels and showed good systemic
exposure. About Lexicon 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, cognitive disorders, and rheumatoid arthritis. 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 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. DATASOURCE: Lexicon
Pharmaceuticals, Inc. CONTACT: Bobbie Faulkner, Manager, Investor
Relations of Lexicon Pharmaceuticals, Inc., +1-281-863-3503, Web
site: http://www.lexpharma.com/
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