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Lexicon Completes Phase 2 Study Of LX1033 In IBS-d
Date:12/3/2013

tment arms and placebo.

"While LX1033 showed similar improvements in stool consistency as compared to the placebo patients who completed the study, there were positive effects on abdominal pain in the treated group that warrant further study," said Pablo Lapuerta, M.D., Lexicon's chief medical officer. "While this initial Phase 2a study was underway, we completed long-term toxicology studies which would allow us to conduct a Phase 2b study at doses informed by the current results and with a duration of 12 weeks, a treatment period that has historically been important to identify clinically meaningful changes as compared to placebo."

In this Phase 2 study of IBS-d, 373 patients were randomized to be treated for 28 days with either placebo or one of three different dose levels of LX1033 for 28 days, 1000 mg twice daily, 500 mg twice daily, and 500 mg three times daily. The primary endpoint was the change from baseline in stool consistency as evaluated by the Bristol Stool Form Scale. A key secondary endpoint was the change from baseline in abdominal pain, and other endpoints included the change in plasma 5-HIAA.

About Lexicon
Lexicon is a biopharmaceutical company focused on discovering breakthrough treatments for human disease.  Lexicon currently has multiple programs in clinical development for diabetes, irritable bowel syndrome, carcinoid syndrome and other indications, all of which were discovered by Lexicon's research team.  Lexicon has used its proprietary gene knockout technology to identify more than 100 promising drug targets.  Lexicon has focused drug discovery efforts on these biologically-validated targets to create its extensive pipeline of clinical and preclinical programs.  For additional information about Lexicon and its programs, please visit www.lexpharma.com.

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