Lexicon Drug Candidate for Cognitive Disorders Successfully Completes Phase 1 Clinical Trial
July 31 2007 - 6:30AM
PR Newswire (US)
- Lead Candidate Advancing To Phase 2 under Symphony Icon
Collaboration - THE WOODLANDS, Texas, July 31
/PRNewswire-FirstCall/ -- Lexicon Pharmaceuticals, Inc.
(NASDAQ:LXRX) 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. About LX6171
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. 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 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/. 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. DATASOURCE: Lexicon
Pharmaceuticals, Inc. CONTACT: Bobbie Faulkner, Manager, Investor
Relations, +1-281-863-3503, or Web site: http://www.lexpharma.com/
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