THE WOODLANDS, Texas,
March 9, 2015 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a
biopharmaceutical company focused on developing breakthrough
treatments for human disease, today announced that it has completed
enrollment in TELESTAR, its pivotal Phase 3 clinical trial of
telotristat etiprate for patients with carcinoid syndrome.
The company expects to announce top-line data from the TELESTAR
trial in the third quarter of 2015.
"The effects of carcinoid syndrome are severely debilitating for
many people's lives, causing them to suffer from life-altering
diarrhea, flushing and pain," said Lonnel Coats, Lexicon's
president and chief executive officer. "Completing enrollment in
this pivotal Phase 3 clinical trial marks an important step in
bringing telotristat etiprate to market to help improve the lives
of these individuals whose carcinoid syndrome is no longer
adequately controlled by somatostatin analog treatment."
TELESTAR is Lexicon's pivotal Phase 3 clinical trial of
telotristat etiprate evaluating the safety and tolerability of
telotristat etiprate and its effect on symptoms associated with
carcinoid syndrome. In total, the trial enrolled 135 patients
with inadequately controlled carcinoid syndrome on background
somatostatin analog therapy, in a randomized, double-blind,
placebo-controlled study of 250mg three times daily and 500mg three
times daily doses of telotristat etiprate over a 12-week treatment
period, followed by a 36-week, open-label extension where all
patients receive 500mg three times daily doses of telotristat
etiprate. The primary efficacy endpoint under evaluation in
the trial is the number of daily bowel movements, with secondary
efficacy endpoints including changes in urinary 5-HIAA levels,
flushing episodes, abdominal pain and quality of life measures.
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 telotristat etiprate (LX1032),
including characterizations of the results of and projected timing
of clinical trials and the potential therapeutic and commercial
potential of telotristat etiprate. 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
telotristat etiprate 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, 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.
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SOURCE Lexicon Pharmaceuticals, Inc.