THE WOODLANDS, Texas,
May 3, 2012 /PRNewswire/ -- Lexicon
Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that an
independent, non-profit organization will provide funding to
support the Phase 2 development of LX4211 in type 1 diabetes.
LX4211, a dual inhibitor of sodium glucose transporter 1 and 2
(SGLT1 and SGLT2), was designed to improve control of blood glucose
through mechanisms that do not require the pancreas to produce
insulin. In type 1 diabetes, also called juvenile diabetes, the
pancreas stops producing enough insulin to support life. People
with type 1 diabetes must monitor their blood sugar levels through
frequent measures of blood glucose in order to select and
administer doses of insulin via shots or an insulin pump, multiple
times every day. With current insulin therapies, even vigilant
management of blood sugar does not eliminate the risk of type 1
diabetes complications such as heart attack, stroke, blindness, and
kidney failure.
"Results we have obtained to date with LX4211 encourage us to
expand its potential application to both type 1 and type 2
diabetes, a unique opportunity for an oral therapy," said Arthur T.
Sands, M.D., Ph.D., Lexicon's president and chief executive
officer. "In this new trial, we hope to see significant reductions
in the amount of insulin required by type 1 patients as well as
more consistent blood sugar control."
LX4211 has already demonstrated beneficial effects on glucose
control in clinical trials conducted to date in type 2 diabetes, or
adult-onset diabetes. Studies have shown that LX4211 lowers blood
sugar levels after meals, reducing glucose absorption from the
gastrointestinal tract and triggering the production of beneficial
hormones such as glucagon-like peptide-1 (GLP-1) that help regulate
blood glucose levels. In addition, LX4211 enhances excretion of
glucose in the urine, which may also help to reduce the need for
insulin, without causing low blood sugar or hypoglycemia. Lexicon
expects to have results from an ongoing Phase 2b trial in type 2
diabetes by mid-year 2012.
About the Clinical Trial in Type 1 Diabetes
The initial Phase 2 proof-of-concept study will be a
randomized, double-blinded, placebo-controlled trial in
approximately 25 adult patients with type 1 diabetes who will
receive LX4211 over a one month treatment period. The primary
endpoint of the study will be reduction of insulin required with
LX4211 as compared to placebo. Secondary endpoints will include
multiple measures of blood sugar to show that LX4211 helps to
maintain glycemic control during the treatment period. Under the
agreement, additional funding could support future Phase 2 trials
of LX4211 in type 1 diabetes.
About Type 1 Diabetes
An estimated 1.3 million people in the U.S. have type 1
diabetes, a chronic disease usually caused by autoimmune
destruction of insulin-producing beta cells of the pancreas. The
resulting decrease in insulin leads to high levels of glucose in
the blood, which in turn can lead to acute metabolic complications
as well as chronic problems with eyes, kidneys, nervous system and
heart. If not properly controlled with insulin therapy, type 1
diabetes can be fatal. Patients with type 1 diabetes are at least
10 times more at risk for cardiovascular disease compared to people
without diabetes. The rate of type 1 diabetes incidence among
children under the age of 14 is estimated to increase by 3%
annually worldwide.
About Lexicon
Lexicon is a biopharmaceutical company focused on
discovering breakthrough treatments for human disease. Lexicon
currently has five drug programs in mid-stage development for
diabetes, carcinoid syndrome, irritable bowel syndrome, rheumatoid
arthritis and glaucoma, all of which were discovered by Lexicon's
research team. Lexicon 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 www.lexpharma.com.
Safe Harbor Statement
This press release contains "forward-looking statements,"
including statements relating to Lexicon's clinical development
of LX4211, including characterizations of the results of and
projected timing of clinical trials of such compounds, 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. Unless specifically indicated
otherwise, results reported as trends were not statistically
significant. Information identifying such important factors is
contained under "Risk Factors" in Lexicon's annual report on Form
10-K for the year ended December 31,
2011, 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.
SOURCE Lexicon Pharmaceuticals, Inc.