Lexicon Reports Initial Clinical Trial Results for LX1031, an Investigational New Drug for Irritable Bowel Syndrome
October 15 2007 - 4:05PM
PR Newswire (US)
PHILADELPHIA and THE WOODLANDS, Texas, Oct. 15
/PRNewswire-FirstCall/ -- Lexicon Pharmaceuticals, Inc.
(NASDAQ:LXRX) presented data regarding Phase 1 clinical trial
results for LX1031 at the annual meeting of the American College of
Gastroenterology in Philadelphia, Pennsylvania. The studies
demonstrated that LX1031 was generally well-tolerated at all dose
levels and that exposure levels in blood were low. A statistically
significant reduction of urinary 5-hydroxyindoleacetic acid
(5-HIAA), a metabolite of serotonin and biomarker for serotonin
production, was observed in subjects who received the highest dose
tested, 2,000 mg per day, for two weeks. Over the fourteen-day
trial, no dose-limiting toxicities were observed. LX1031 was
developed as an orally-administered potential treatment for
irritable bowel syndrome (IBS) and other gastrointestinal (GI)
disorders. Preclinical studies demonstrated that LX1031 lowers
serotonin levels in the intestine without affecting levels in the
brain. "We are pleased with the results of our initial human
studies of LX1031," said Philip M. Brown, M.D., J.D., Lexicon's
vice president of clinical development. "The compound was well
tolerated, consistent with our preclinical observations, and we are
encouraged by the 5-HIAA biomarker results. We look forward to
progressing LX1031 into Phase 2 clinical trials in 2008." About
LX1031 and Irritable Bowel Syndrome Based on findings from
Lexicon's proprietary knock-out mouse technology, LX1031 was
developed by Lexicon's small molecule drug discovery team as an
orally-administered inhibitor of tryptophan hydroxylase, a key
enzyme in the synthesis of serotonin. Serotonin is a
neurotransmitter found primarily in the brain and GI tract, where
it has distinctly different functions. In the brain, serotonin is
associated with mood and behavior, whereas in the GI tract it
stimulates motility and signals feelings of discomfort and nausea.
The dysregulation of serotonin is thought to be associated with
functional GI disorders, including IBS. IBS is a functional bowel
disorder of the GI tract characterized by changes in bowel habits
that are not specifically associated with any particular disease.
Symptoms include diarrhea, constipation, bloating, gas, abdominal
pain, and cramping. As many as one in five American adults suffers
from IBS, making it the most common disorder seen by
gastroenterologists and one of the most common disorders seen by
primary care physicians. LX1031 is being developed in a product
development collaboration with Symphony Capital Partners, L.P. and
its co-investors. About Lexicon Lexicon is a biopharmaceutical
company focused on the discovery and development of breakthrough
treatments for human disease. Lexicon currently has development
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/. Safe Harbor Statement This press release
contains "forward-looking statements," including statements
relating to Lexicon's clinical development of LX1031 and the
potential therapeutic and commercial potential of LX1031. 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 LX1031 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: Chas Schultz, Director of Financial
Analysis of Lexicon Pharmaceuticals, Inc., +1-281-863-3421, Web
site: http://www.lexpharma.com/
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