Lexicon Files Investigational New Drug Application for LX2931 as a Potential Treatment for Rheumatoid Arthritis
November 12 2007 - 8:00AM
PR Newswire (US)
THE WOODLANDS, Texas, Nov. 12 /PRNewswire-FirstCall/ -- Lexicon
Pharmaceuticals, Inc. (NASDAQ:LXRX) announced today that it has
submitted an investigational new drug (IND) application to the U.S.
Food and Drug Administration (FDA) for LX2931, an oral drug
candidate for rheumatoid arthritis and other autoimmune conditions.
The initial Phase 1 clinical trial of LX2931 is planned as a
double-blind, randomized, placebo-controlled, ascending single-dose
study in healthy volunteers, designed to evaluate the safety,
tolerability, and pharmacokinetics of LX2931. Lexicon expects to
initiate clinical trials with LX2931 following FDA review. "As an
orally-delivered modulator of lymphocyte activity, we believe
LX2931 has potential to be an important new therapy for rheumatoid
arthritis and other autoimmune disorders," said Philip M. Brown,
M.D., J.D., vice president of clinical development at Lexicon. "We
can now add immunology to the list of therapeutic areas with
clinical-stage compounds from Lexicon's drug discovery pipeline."
Rheumatoid arthritis is an autoimmune disorder characterized by
stiffness, pain, swelling, and limitation of motion in multiple
joints. More than 2 million Americans suffer from rheumatoid
arthritis, which, if left untreated, can result in disfigurement
and disability from irreversible joint damage. According to the
National Institutes of Health (NIH), autoimmune disorders affect
between 14.7 and 23.5 million people in the United States. LX2931
was developed at Lexicon as an inhibitor of a key enzyme in the
sphingolipid pathway, which controls lymphocyte circulation and
trafficking to peripheral sites in the body during an inflammatory
response. As with Lexicon's other clinical and preclinical
programs, the LX2931 target enzyme was identified through Lexicon's
gene knockout program, Genome5000(TM). Knockout mice lacking this
enzyme had a significantly decreased number of circulating
lymphocytes and were resistant to inflammation in a wide range of
assays modeling processes involved in the development of arthritis
and other autoimmune conditions. Because inappropriate activation
of lymphocytes is associated with autoimmune disorders, including
rheumatoid arthritis, reduction of lymphocyte buildup at sites of
disease activity holds promise as a new therapeutic mechanism.
Preclinical studies with LX2931 showed a robust and reproducible
reduction of inflammation in animal models of arthritis.
Additionally, LX2931-treated animals showed a rapid, dose-dependent
reduction in peripheral lymphocyte counts. 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, cognitive
disorders, and autoimmune diseases. 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.
Lexicon's drug discovery system has been so productive that Lexicon
plans to move ten drug candidates into human clinical trials by the
end of 2010. This strategic initiative is referred to as the 10to10
program. 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
LX2931 and the potential therapeutic and commercial potential of
LX2931. 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 LX2931 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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