Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced today that top-line data from its TELECAST Phase 3 study showed results of telotristat etiprate in treating carcinoid syndrome in cancer patients with metastatic neuroendocrine tumors consistent with the clinical benefit observed in its pivotal TELESTAR study. The TELECAST study was designed as a companion to TELESTAR primarily to provide additional safety exposure while further evaluating telotristat etiprate's activity in carcinoid syndrome. TELECAST mostly enrolled patients treated with somatostatin analog (SSA) therapy, the current standard of care, with carcinoid syndrome characterized by less severe bowel movement frequency than those patients in the TELESTAR study, together with a smaller number of carcinoid syndrome patients not treated with SSA therapy.
Telotristat etiprate 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 (p<0.001 for both dose arms compared to placebo). In addition, despite the lower baseline bowel movement frequency than in TELESTAR, telotristat etiprate achieved statistically significant reductions in daily bowel movement frequency over the 12 weeks of the study (p=0.004 for the 250 mg dose arm and p<0.001 for the 500 mg dose arm compared to placebo). Safety and tolerability was one of the primary objectives of the TELECAST study, and telotristat etiprate was well tolerated during the double-blind treatment period, with profiles similar to placebo for both the 250 mg and 500 mg dose arms and no overall differences observed in gastrointestinal disorders or psychiatric disorders, including changes in mood.
"We are very pleased with the efficacy and safety results of telotristat etiprate in this study, notably including evidence of benefit in a patient population whose bowel movement frequency was lower at baseline than was the case in TELESTAR," said Lexicon Executive Vice President and Chief Medical Officer Pablo Lapuerta, M.D. "TELECAST was intended to complement our pivotal Phase 3 trial, TELESTAR. We now have experience in more than 200 patients with carcinoid syndrome, with TELECAST contributing consistent efficacy data and favorable safety results. The data further support that the compound is acting directly on the cause of carcinoid syndrome, by reducing serotonin production within tumor cells."
No comments:
Post a Comment