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Lexicon Pharmaceuticals Provides Clinical Pipeline Update And Reports 2012 Fourth Quarter And Full Year Financial Results
Date:2/21/2013

ions in body weight and blood pressure. In addition, Lexicon initiated a study in type 2 diabetes patients with renal impairment.
  • Telotristat etiprate (LX1032):  Lexicon initiated a pivotal Phase 3 clinical trial of telotristat etiprate, an inhibitor of tryptophan hydroxylase that reduces peripheral serotonin production without affecting brain serotonin levels. 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.  The study is expected to enroll approximately 105 patients.  Lexicon reported data from an open-label Phase 2 trial in which telotristat etiprate showed evidence of clinical benefit across several endpoints in carcinoid syndrome patients. Benefits included reductions in bowel movement frequency, decreased urinary 5-HIAA (a biomarker of serotonin synthesis), and improvements in patient-reported relief of symptoms. Lexicon received Orphan Drug designation for telotristat etiprate from the U.S. Food and Drug Administration (FDA) for the treatment of carcinoid syndrome, having previously obtained Fast Track designation from the FDA and Orphan Drug designation from the European Medicines Agency (EMA). In addition to ongoing development in carcinoid syndrome, Lexicon also initiated a Phase 2 proof-of-concept study of telotristat etiprate in patients with ulcerative colitis.
  • LX1033: Lexicon initiated a Phase 2 clinical trial of LX1033, an inhibitor of tryptophan hydroxylase that acts locally in the gastrointestinal tract to reduce serotonin production, in patients with diarrhea-predominant IBS (IBS-d). The Phase 2 trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safe
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  • SOURCE Lexicon Pharmaceuticals, Inc.
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