THE WOODLANDS, Texas,
May 10, 2013 /PRNewswire/ -- Lexicon
Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that it is
progressing into the placebo-controlled portion of its Phase 2
clinical trial of LX4211 in patients with type 1 diabetes, having
successfully completed the open-label, pioneer portion of the
trial. LX4211 is an investigational, oral, dual inhibitor of
sodium glucose transporters 1 and 2 (SGLT1 and SGLT2).
The pioneer phase of the study was designed to gain important
initial information regarding the safety of co-administration of
LX4211 with insulin in this, the first test of dual inhibition of
SGLT1 and SGLT2 in patients with insulin-dependent type 1
diabetes. The successful conclusion of the 28-day pioneer
group enables the initiation of the placebo-controlled expansion
phase of the study to commence in up to 30 patients with type 1
diabetes. Based on the results observed in the pioneer group,
Lexicon has identified the 400 mg once daily dose of LX4211 as the
appropriate treatment for the expansion phase of the trial.
"This is a very important first step in the future development
of LX4211 in type 1 diabetes," said Dr. Arthur Sands, president and chief executive
officer of Lexicon. "The preliminary results are very encouraging
and provide a strong rationale for moving into the expansion phase
of the trial."
LX4211, a first-in-class dual inhibitor, reduces the amount of
glucose that enters the bloodstream from the gastrointestinal (GI)
tract by inhibiting SGLT1, the major transporter responsible for
glucose absorption, and enhances glucose excretion in the urine by
inhibiting SGLT2, the major transporter responsible for glucose
reabsorption by the kidney. Lexicon has previously demonstrated
that SGLT1 inhibition by LX4211 increases GLP-1 and PYY, GI
hormones associated with glycemic control and appetite. Lexicon is
also developing LX4211 for type 2 diabetes with Phase 3 planning
ongoing.
About Type 1 Diabetes
It is estimated that every year in the
United States, more than 15,000 young people under the age
of 20 years are diagnosed with type 1 diabetes mellitus. Type 1
diabetes is a disease caused by an autoimmune destruction of the
insulin-producing beta-cells in the pancreas, resulting in an
absolute insulin deficiency. Maintaining glycemic control is a key
therapeutic goal in order to delay or prevent the complications of
diabetes including retinopathy, nephropathy, neuropathy and
macrovascular disease. Insulin use to maintain tight glycemic
control presents significant challenges for patients, both
logistically and medically, with constant approximations and
adjustments made to accommodate various meals and activity
levels. Despite advances in insulin therapy (fast-acting
mealtime analogs, long-acting basal analogs, and insulin pump
therapy) and glycemic monitoring (continuous glucose monitoring),
tight glycemic control is still associated with hypoglycemia.
A new therapy used in combination with insulin that offers
the advantages of improved glycemic control, reduced and simpler
insulin regimen, and lower incidence of hypoglycemia would offer a
significant advancement in therapy for this serious chronic disease
which still results in excess morbidity and mortality.
About Lexicon
Lexicon is a biopharmaceutical company
focused on discovering breakthrough treatments for human
disease. Lexicon currently has multiple programs in clinical
development for diabetes, irritable bowel syndrome, carcinoid
syndrome and other indications, 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,
characterizations of the results of and projected timing of
clinical trials, and the potential therapeutic and commercial
potential of LX4211. This press release also contains
forward-looking statements regarding 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 preclinical and clinical
development of its 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
"Risk Factors" in Lexicon's annual report on Form 10-K for the year
ended December 31, 2012, 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.