Lexicon presents data from TELECAST Phase 3 study at NANETS
Lexicon Pharmaceuticals announced that data from its TELECAST Phase 3 study were presented at the 2016 Annual Symposium of the North American Neuroendocrine Tumor Society, held September 30 to October 1 in Jackson, Wyoming, by Dr. Marianne Pavel in a presentation, entitled "Efficacy and Safety Results of Telotristat Ethyl in Patients with Carcinoid Syndrome During the Double-blind Treatment Period of the TELECAST Phase 3 Clinical Trial." Safety and tolerability was one of the primary objectives of the TELECAST study, and telotristat ethyl was well tolerated during the double-blind treatment period. Across all three treatment arms (placebo, 250 mg, 500 mg, each taken three times daily), the incidence of treatment-emergent adverse events were 80.8%, 100% and 84.0%, respectively; the incidence of serious AEs were 19.2%, 4.0% and 8.0%, respectively; and discontinuation due to AEs were 3.8%, 8.0% and 0%, respectively. AEs of depression or depressed mood were seen in two patients (7.7%) in the placebo arm and one (4.0%) in each of the telotristat ethyl treatment arms. Gastrointestinal AEs were seen in 57.7%, 64.0% and 36.0% of patients in the placebo, 250 mg and 500 mg treatment arms, respectively. Telotristat ethyl met the study's primary efficacy endpoint, the percent change from baseline in urinary 5-hydroxyindoleacetic acid (5-HIAA, the main metabolite of serotonin) at week 12, the final week of the double-blind treatment portion of the study (pless than0.001 for both telotristat ethyl arms compared to placebo). The placebo-adjusted change in 5-HIAA was -54.0% and -89.7% for the 250 mg and 500 mg treatment arms, respectively. In addition, despite the lower baseline bowel movement frequency than in TELESTAR, telotristat ethyl achieved statistically significant reductions in daily bowel movement frequency over the 12 weeks of the study (p=0.004 for the 250 mg treatment arm and pless than0.001 for the 500 mg treatment arm compared to placebo). Baseline mean daily bowel movement frequency was 2.2, 2.5 and 2.8 in the placebo, 250 mg and 500 mg arms. Patients in the 250 mg and 500 mg dose arms experienced noteworthy reductions in daily bowel movement frequency early in the study that tended to increase over time. The placebo-adjusted reduction in daily bowel movement frequency over the entire 12-week period was -0.45 and -0.54 for the 250 mg and 500 mg treatment arms, respectively. Notably, 40% of patients in each of the telotristat ethyl treatment arms achieved a greater than or equal to30% reduction in BM frequency for at least 50% of the days in the double-blind treatment period, while not a single patient in the placebo arm achieved that result (p=0.001 for both doses compared to placebo).