THE WOODLANDS, Texas,
July 9, 2014 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced
today that JDRF, the world's largest non-profit supporter of type 1
diabetes (T1D) research, will provide funding to support a Phase 2,
randomized, double-masked, placebo-controlled clinical trial to
evaluate the efficacy and safety of LX4211 in a younger population
with T1D. Up to 76 individuals with T1D, younger than 30
years of age and with HbA1c levels greater than 9.0%, are expected
to be randomly assigned to receive either placebo or a once daily
400mg dose of LX4211 and complete the 12-week treatment
period. The primary objective of this study is to demonstrate
the superiority of LX4211 versus placebo as adjunct to insulin
treatment on HbA1c reduction at 12 weeks as well as several
secondary endpoints, including reduced variability in blood glucose
levels and lower insulin needs.
"JDRF has a strategic T1D research plan designed to deliver a
sustained stream of new life-changing therapies, so we are pleased
to collaborate with Lexicon on the development of LX4211 in T1D,"
said Sanjoy Dutta, Ph.D., JDRF's
assistant vice president, translational development. "This
collaboration is part of JDRF's Glucose Control Research Program
whose goal is to develop and deliver improved insulin and
non-insulin adjunct therapies that progressively improve glucose
and overall metabolic control in individuals with T1D. We believe
that LX4211's dual SGLT1/SGLT2 inhibitory mechanism offers an
innovative and exciting opportunity to deliver on this goal and
address an important unmet medical need in those with T1D
struggling to achieve optimal glucose control target levels."
"The results from our previous Phase 2 study of LX4211 in type 1
diabetes have encouraged us to also explore its potential
application in this younger population for whom managing glucose
variability is an especially difficult challenge and in which the
significant majority are unable to achieve HbA1c targets," said
Pablo Lapuerta, M.D., Lexicon's executive vice president and chief
medical officer. "Importantly, we hope to continue to see
improvement in glycemic control with a longer treatment period
combined with reductions in the amount of insulin required and
related improvements in quality of life in this population of high
unmet medical need. This study complements our ongoing
preparations for Phase 3 in type 1 diabetes, which are proceeding,
as well as our plans for LX4211 in type 2 diabetes."
LX4211 is an oral, first-in-class, dual inhibitor of sodium
glucose transporters 1 and 2 (SGLT1 and SGLT2) that is designed to
lower blood glucose levels through two insulin-independent
mechanisms of action. In a previous Phase 2 clinical trial of
LX4211 in type 1 diabetes, LX4211 treatment was shown to reduce
mean HbA1c by 0.55% compared to a reduction of only 0.06% with
placebo (p=0.002) over a four-week treatment period. At the same
time, LX4211 reduced the total daily mealtime bolus insulin dose by
32% compared to 6% for placebo (p=0.007), while reducing
variability in blood glucose levels. These improvements were
accompanied by significantly more time spent in the target glucose
range of 70-180 mg/dl, a significant reduction in time in
hyperglycemic range, and no increase in hypoglycemia.
About Type 1 Diabetes
Type 1 diabetes is a serious
condition affecting more than one million people in the United States, both children and adults.
Type 1 diabetes is an autoimmune disease in which a person's
pancreas stops producing insulin, a hormone that enables people to
get energy from food. It occurs when the body's immune system
attacks and destroys the insulin-producing cells in the pancreas.
Insulin is a required treatment, with few additional treatment
options. The effectiveness of insulin is limited by concerns
about potentially serious hypoglycemia; therefore, most patients
with type 1 diabetes do not achieve their targets for glucose
control. In addition, insulin therapy does not necessarily prevent
the possibility of the disease's serious complications, which may
include kidney failure, blindness, nerve damage, heart attack and
stroke. As an oral agent, LX4211 is designed to delay the
absorption of glucose in the gastrointestinal tract and enhance
glucose excretion in the kidney, allowing glucose control to
improve and insulin doses to be reduced.
About Lexicon
Lexicon is a biopharmaceutical company
focused on developing breakthrough treatments for human
disease. Lexicon has clinical-stage drug programs for
diabetes, 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. For additional information about
Lexicon and its programs, please visit www.lexpharma.com.
About JDRF
JDRF is the leading global organization
funding type 1 diabetes (T1D) research. JDRF's goal is to
progressively remove the impact of T1D from people's lives until we
achieve a world without T1D. JDRF collaborates with a wide spectrum
of partners and is the only organization with the scientific
resources, regulatory influence, and a working plan to better
treat, prevent, and eventually cure T1D. As the largest charitable
supporter of T1D research, JDRF is currently sponsoring
$568 million in scientific research
in 17 countries. For additional information about JDRF,
please visit www.jdrf.org.
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 of LX4211, and
the potential therapeutic and commercial potential of LX4211.
The 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 meet its capital
requirements, 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 "Risk Factors" in
Lexicon's annual report on Form 10-K for the year ended
December 31, 2013, 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.