Phase III TELESTAR study results with Xermelo in carcinoid syndrome published in Clinical Therapeutics.- Lexicon Pharma.

Lexicon Pharmaceuticals announced that new Xermelo (telotristat ethyl) data from the randomized, double-blind, placebo-controlled Phase III TELESTAR (Telotristat Etiprate for Somatostatin Analog Not Adequately Controlled Carcinoid Syndrome) study in carcinoid syndrome were published in Clinical Therapeutics. The March issue of Clinical Therapeutics provides the first report of the effects of Xermelo on changes in weight in patients with neuroendocrine tumors (NETs) and carcinoid syndrome that participated in the TELESTAR study.

Of the 120 patients with weight data available, up to 32.5% of patients treated with Xermelo experienced significant, dose-dependent weight gain (more than 3% from baseline). Only 5.1% of patients on placebo experienced weight gain. Importantly, patients with weight gain experienced improvement in carcinoid syndrome control, as seen in reduction of bowel movement frequency and in parameters of nutritional status associated with positive changes in patient-reported outcomes compared with patients with stable weight or weight loss. Those patients also experienced reduced u5-HIAA levels. Patients with weight gain also experienced fewer serious adverse events than patients with stable weight or weight loss.