Lexicon Pharmaceuticals,
Inc. 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.
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