Phase 2 study of LX2931 for treatment of rheumatoid arthritis

Lexicon Pharmaceuticals announced it has initiated a Phase 2 clinical trial of LX2931 in patients with rheumatoid arthritis. This 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.

 LX2931, an orally-delivered, small molecule drug candidate, inhibits sphingosine-1-phosphate (S1P) lyase, an enzyme identified as a promising new target on a pathway associated with regulation of the human immune system.

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