BioCentury
ARTICLE | Clinical News

Telotristat etiprate: Additional Phase II data

October 15, 2012 7:00 AM UTC

An open-label, dose escalation, European Phase II trial in 15 patients with metastatic carcinoid syndrome who were refractory or intolerable to somatostatin analog therapy showed that thrice-daily telotristat etiprate produced a significant median reduction of 46.4% in the number of bowel movements at week 12 compared to baseline, the primary efficacy endpoint (p<0.001). Lexicon said that the number of daily bowel movements steadily decreased over time. On secondary endpoints, 75% of patients reported an improvement in relief of carcinoid symptoms at week 12. Additionally, telotristat etiprate significantly improved stool consistency from baseline (p<0.001) and non-significantly reduced abdominal pain (p=0.09) and the number of cutaneous flushing episodes from baseline (p=0.052). Furthermore, telotristat etiprate reduced urinary 5-HIAA levels, a biomarker of serotonin synthesis, from baseline by 68.3% at week 8 (p=0.019) and by 72.7% at week 12 (p=0.031).

Patients received each of thrice-daily 150, 250, 350 and 500 mg telotristat etiprate for 14 days until reaching a maximal dose, which was then continued until completion of the study. Telotristat etiprate was well tolerated with no dose-limiting toxicities (DLTs) reported. There were 3 serious adverse events reported, all unrelated to telotristat etiprate. Data were presented at the North American Neuroendocrine Tumor Society meeting in San Diego. Last year, Lexicon reported preliminary data from the trial showing that 5 of 6 evaluable patients achieved sustained reductions of >=30% in bowel movement frequency (see BioCentury, Aug. 15, 2011). ...