Lexicon Pharma Announces Closing of Enrollment in Pivotal Phase 3 Clinical Trial of Telotristat Etiprate

Lexicon Pharmaceuticals, Inc.

, 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.