Lexicon Completes Phase 1 Clinical Trial and Initiates Phase 2 Clinical Trial of LX4211 in Patients With Type 2 Diabetes
September 15 2009 - 6:30AM
PR Newswire (US)
- Lexicon's Fourth Drug Candidate in Phase 2 Development - Oral
Drug Candidate Inhibits SGLT2, a Potential Target for Diabetes -
Phase 1 Results Support Once Daily Dosing in Patients with Type 2
Diabetes THE WOODLANDS, Texas, Sept. 15 /PRNewswire-FirstCall/ --
Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), a biopharmaceutical
company focused on discovering breakthrough treatments for human
disease, obtained favorable results from recently completed Phase 1
studies of LX4211 and announced today that it has initiated a Phase
2 clinical trial of the drug candidate in patients with type 2
diabetes mellitus. LX4211 is an orally-delivered, small molecule
drug candidate that inhibits the sodium glucose transporter 2
(SGLT2). LX4211 is Lexicon's fourth drug candidate currently being
tested in Phase 2 clinical trials. "LX4211 offers an opportunity to
treat diabetes by increasing urinary glucose excretion through a
mechanism of action that is expected to avoid some of the
disadvantages of existing diabetes drugs that result in storage of
excess glucose," said Brian P. Zambrowicz, Ph.D., executive vice
president and chief scientific officer at Lexicon. "By contrast,
LX4211 through inhibition of SGLT2 has the potential to reduce
caloric load and thereby enhance overall glucose homeostasis in
patients with type 2 diabetes." In the recently completed Phase 1
clinical trial in normal healthy volunteers, LX4211 was well
tolerated at all dose levels and produced a dose-dependent increase
in urinary glucose excretion. LX4211 also demonstrated a favorable
pharmacokinetic profile supporting the potential for once daily
dosing. Adverse events were generally mild and were distributed
across all dose groups, including the placebo group. Based on the
Phase 1 clinical results, Lexicon has initiated a Phase 2 clinical
trial to evaluate the safety and tolerability of two dose levels of
LX4211 and its effect on diabetes biomarkers including: fasting
blood glucose, urinary glucose excretion and response to oral
glucose tolerance testing in patients with type 2 diabetes. The
four-week, randomized, double-blind, placebo-controlled study will
be conducted in the United States and is expected to enroll 36
patients with type 2 diabetes. In addition to LX4211, Lexicon has
three other drug candidates progressing in Phase 2 clinical trials:
LX1031 for irritable bowel syndrome, LX1032 for carcinoid syndrome
and LX2931 for rheumatoid arthritis. For more information about
Lexicon's clinical development programs, please visit
http://www.lexpharma.com/. About the Target LX4211 was developed at
Lexicon as a potent inhibitor of the sodium glucose transporter 2
(SGLT2), a transporter responsible for the majority of glucose
reabsorption by the kidneys. Lexicon found that mouse knockouts
engineered to lack the SGLT2 gene are healthy and require less
insulin to manage a glucose challenge. Compounds developed by
Lexicon that inhibit SGLT2 may potentially treat diabetes by
increasing urinary glucose excretion, thereby lowering blood
glucose levels as well as caloric load. About Diabetes Diabetes
mellitus is a common metabolic disorder associated with abnormally
high blood sugar levels. Diabetes is classified as either type 1,
which is characterized by severely diminished insulin production,
or type 2, which is characterized by moderately diminished insulin
production in conjunction with insulin resistance (insensitivity of
the tissues of the body to insulin). Insulin is a hormone that
regulates blood glucose levels. Diabetes can seriously impair
overall quality of life and may lead to multiple complications
including heart disease, stroke, and kidney failure. According to
the International Diabetes Federation, more than 245 million people
have diabetes, with type 2 diabetes being the most prevalent. About
Lexicon Lexicon is a biopharmaceutical company focused on
discovering breakthrough treatments for human disease. Lexicon
currently has five drug candidates in development for autoimmune
disease, carcinoid syndrome, diabetes, glaucoma and irritable bowel
syndrome, all of which were discovered by the company's research
team. The company has used its proprietary gene knockout technology
to identify more than 100 promising drug targets. Lexicon has
focused drug discovery efforts on these biologically-validated
targets to create its extensive pipeline of clinical and
preclinical programs. 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
LX4211 and the potential therapeutic and commercial potential of
LX4211. 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 LX4211 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, 2008, 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: Jason Ray,
Manager, Corporate Communications and Investor Relations of Lexicon
Pharmaceuticals, Inc., +1-281-863-3225, Web Site:
http://www.lexpharma.com/
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