Lexicon completes patient enrollment in Phase III trial of telotristat etiprate

TELESTAR will evaluate the safety and tolerability of telotristat etiprate and its effect on symptoms associated with carcinoid syndrome, while top-line data is expected to be reported in the third quarter of 2015.

Lexicon president and chief executive officer Lonnel Coats said: "The effects of carcinoid syndrome are severely debilitating for many people’s lives, causing them to suffer from life-altering diarrhea, flushing and pain.

"Completing enrollment in this pivotal Phase III 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."

A total of 135 patients with inadequately controlled carcinoid syndrome on background somatostatin analog therapy have been enrolled in this randomized, double-blind, placebo-controlled trial.

In the trial patients are given 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 trial’s primary efficacy endpoint under evaluation is the number of daily bowel movements, while the secondary efficacy endpoints include changes in urinary 5-HIAA levels, flushing episodes, abdominal pain and quality of life measures.