LX 1032 (telotristat etiprate) meets primary endpoint in cancer patients with carcinoid syndrome- Lexicon Pharmaceuticals

Lexicon Pharmaceuticals announced that the pivotal TELESTAR Phase III clinical trial of oral LX 1032 (telotristat etiprate) met its primary endpoint, showing benefit in treating cancer patients with carcinoid syndrome that is not adequately controlled by the current standard of care. Top-line results from the Phase III study show that patients who added telotristat etiprate to the standard of care at both the 250 mg and 500 mg doses experienced a statistically significant reduction from baseline compared to placebo in the average number of daily bowel movements over the 12-week study period (p<0.001), meeting the study's primary endpoint. if approved, telotristat etiprate would be the first oral treatment successfully developed for carcinoid syndrome and the first addition to the standard of care in more than 16 years.>

Comment: Lexicon received Fast Track designation and Orphan Drug status for telotristat etiprate from the FDA in 2008 and 2012, respectively. The company plans to announce complete results from the Phase III TELESTAR study at an upcoming scientific conference.