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Lexicon Initiates Phase 2 Clinical Trial of LX2931 in Patients With Rheumatoid Arthritis
Date:8/4/2009

eased the inflammatory response in multiple models of arthritis, inflammation and transplantation.

The Phase 2 clinical trial is designed as a 12-week, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LX2931 and its effects on symptoms associated with rheumatoid arthritis. The study will include multiple centers in the United States and Eastern Europe. The company expects to enroll up to 120 patients with rheumatoid arthritis on stable methotrexate therapy. Three dose levels will be evaluated: a 70 mg dose, a 110 mg dose and a 150 mg dose, each administered once daily. The primary endpoint will be the ACR20, which is defined by the American College of Rheumatology (ACR) as a 20 percent improvement in symptoms associated with rheumatoid arthritis. Multiple secondary endpoints will also be evaluated, including ACR50, ACR70 and DAS28.

In addition to LX2931, Lexicon has two other drug candidates progressing in Phase 2 clinical trials, LX1031 for irritable bowel syndrome and LX1032 for carcinoid syndrome. Furthermore, LX4211 for diabetes has recently completed dosing in a Phase 1 clinical trial. For more information about Lexicon's clinical development programs, please visit www.lexpharma.com.

About Rheumatoid Arthritis

Lymphocytes are a type of white blood cell that play an important role in the immune system. Inappropriate activation of lymphocytes is often associated with autoimmune diseases, a spectrum of disorders in which the immune system malfunctions and causes the body to attack its own organs, tissues and cells. Rheumatoid arthritis is an autoimmune disorder characterized by stiffness, pain, swelling, and limitation of motion in multiple joints. More than 2 million Americans suffer from rheumatoid arthritis, which, if left untreated, can result in disfigurement and disabilit
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SOURCE Lexicon Pharmaceuticals, Inc.
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