THE WOODLANDS, Texas,
Oct. 1, 2013 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced
today that LX4211, a first-in-class, dual inhibitor of sodium
glucose transporters 1 and 2 (SGLT1 and SGLT2), successfully met
the primary endpoint of reducing post-prandial glucose, in a study
of patients with type 2 diabetes and moderate to severe renal
impairment. Reducing elevated post-prandial glucose, high
blood sugar levels after meals, is a key objective of diabetes
therapy.
In a placebo-controlled, proof-of-concept study, LX4211 provided
clinically meaningful and statistically significant reductions
(p<0.05) in post-prandial glucose in diabetes patients with
moderate to severe renal impairment (Stage 3 and 4 kidney disease).
Importantly, these effects were maintained in a sub-group with the
most advanced renal impairment, pre-defined as those with
glomerular filtration rate (GFR) less than 45 ml/min/1.73
m2. LX4211 also produced significant elevations in
GLP-1, a hormone involved in control of glucose and appetite.
Renal impairment occurs in approximately 30% of patients with
type 2 diabetes and represents a major unmet medical need with
limited treatment options. LX4211's inhibition of SGLT1 in
the gastrointestinal (GI) tract, reducing glucose absorption and
triggering GLP-1 secretion, offers the potential for treating this
medically challenging population with compromised kidney
function. In previous Phase 2 studies, LX4211 improved
glycemic control in patients with type 2 diabetes with normal renal
function.
"Our hypothesis was that LX4211 would improve glycemic control
even in patients with the greatest degree of renal impairment due
to its inhibition of SGLT1 in the GI tract," said Pablo Lapuerta, M.D., Lexicon's chief medical
officer. "The post-prandial glucose reductions and GLP-1
elevations observed in this study population support the rationale
for demonstrating effective HbA1c reduction in a larger,
longer-term Phase 3 trial, and provide further support for the
clinical differentiation of LX4211 as a first-in-class dual SGLT1
and SGLT2 inhibitor."
In this multicenter study, 30 patients with poorly controlled
type 2 diabetes and moderate to severe renal impairment were
randomized to either placebo or a 400 mg dose of investigational
drug LX4211 taken orally once per day before breakfast. Patients'
post-prandial glucose was measured after a standardized meal both
at baseline before treatment and after one week of therapy. In
addition to achieving the primary efficacy objective of
post-prandial glucose reduction, there were no serious adverse
events observed in the study and no discontinuations of LX4211 due
to adverse events. Lexicon plans to present full results of the
study at scientific congresses in 2014.
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 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 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,
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.