THE WOODLANDS, Texas,
March 25, 2015 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a
biopharmaceutical company focused on developing breakthrough
treatments for human disease, today announced that it has commenced
screening in its first pivotal Phase 3 clinical trial of
sotagliflozin for type 1 diabetes.
"We are pleased to achieve this important milestone in
sotagliflozin's Phase 3 development on schedule," said Lonnel
Coats, Lexicon's president and chief executive officer. "We believe
this first-in-class, dual SGLT1 and SGLT2 inhibitor has the
potential to provide unique benefits to individuals with type 1
diabetes."
Lexicon will be conducting two pivotal Phase 3 clinical trials
of sotagliflozin, one in North
America and another primarily in Europe. Each pivotal
trial is a randomized, double-blind, placebo-controlled,
parallel-group, multicenter study to evaluate the efficacy, safety
and tolerability of sotagliflozin in adult patients with type 1
diabetes. Two dose levels of sotagliflozin, 200mg and 400mg
once daily, will be tested along with placebo. The primary
efficacy endpoint under evaluation will be reduction of A1C versus
placebo on optimized insulin treatment at 24 weeks, with secondary
endpoints including percentage of patients achieving A1C levels of
less than 7%, reduction in meal-time, or bolus, insulin use and
weight loss. Additional information on the North American
study can be found at www.clinicaltrials.gov by using the
identifier NCT02384941.
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.
Safe Harbor Statement
This press release contains
"forward-looking statements," including statements relating to
Lexicon's clinical development of sotagliflozin (LX4211), including
characterizations of the results of and projected timing of
clinical trials and the potential therapeutic and commercial
potential of sotagliflozin. In addition, 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 meet its capital requirements, successfully
conduct clinical development of sotagliflozin and preclinical and
clinical development of its other potential drug candidates, 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, 2014, 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.
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SOURCE Lexicon Pharmaceuticals, Inc.