THE WOODLANDS, Texas, Oct. 12, 2012 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced today that it has initiated a registrational, Phase 3 clinical trial of telotristat etiprate, an investigational new drug candidate for the treatment of carcinoid syndrome. Carcinoid syndrome is a chronic condition caused by neuroendocrine tumors that usually originate from the gastrointestinal tract. It is characterized by severe diarrhea and flushing episodes with long-term consequences including malnutrition, heart disease, and death. Carcinoid syndrome has been linked to excess production of serotonin by metastatic tumor cells.
Telotristat etiprate is an oral drug candidate designed to treat carcinoid syndrome by reducing serotonin production in patients with metastatic carcinoid tumors. Telotristat etiprate has Fast Track status and Orphan Drug designation from the U.S. Food and Drug Administration, and Orphan designation from the European Medicines Agency.
"The registrational, Phase 3 study is designed to evaluate the efficacy and safety of telotristat etiprate in patients with carcinoid syndrome that is refractory to somatostatin therapy," said Pablo Lapuerta M.D., senior vice president and chief medical officer at Lexicon. "We are encouraged by the consistent clinical results obtained to date in two Phase 2 trials that showed telotristat etiprate significantly improved multiple dimensions of carcinoid syndrome with a favorable safety profile."
The Phase 3 registrational trial is a 12-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of telotristat etiprate as a new treatment for carcinoid syndrome that is refractory to current therapy. Two dose levels of telotristat etiprate, 250mg and 500mg three times daily (TID), will be tested along with placebo. The study will include approximately 105 patients with refractory carcinoid syndrome on background somatostatin analog therapy, assigned equally among the 3 treatment groups using a 1:1:1 randomization plan. After the 12-week treatment period, patients will enter a 36 week open-label extension period where all patients will receive telotristat etiprate 500mg TID.