Lexicon Files Investigational New Drug Application For LX2931 As A Potential Treatment For Rheumatoid Arthritis

Main Category: Arthritis / Rheumatology
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 13 Nov 2007 - 0:00 PDT

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Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) announced that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for LX2931, an oral drug candidate for rheumatoid arthritis and other autoimmune conditions. The initial Phase 1 clinical trial of LX2931 is planned as a double-blind, randomized, placebo-controlled, ascending single-dose study in healthy volunteers, designed to evaluate the safety, tolerability, and pharmacokinetics of LX2931. Lexicon expects to initiate clinical trials with LX2931 following FDA review.

"As an orally-delivered modulator of lymphocyte activity, we believe LX2931 has potential to be an important new therapy for rheumatoid arthritis and other autoimmune disorders," said Philip M. Brown, M.D., J.D., vice president of clinical development at Lexicon. "We can now add immunology to the list of therapeutic areas with clinical-stage compounds from Lexicon's drug discovery pipeline."

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 disability from irreversible joint damage. According to the National Institutes of Health (NIH), autoimmune disorders affect between 14.7 and 23.5 million people in the United States.

LX2931 was developed at Lexicon as an inhibitor of a key enzyme in the sphingolipid pathway, which controls lymphocyte circulation and trafficking to peripheral sites in the body during an inflammatory response. As with Lexicon's other clinical and preclinical programs, the LX2931 target enzyme was identified through Lexicon's gene knockout program, Genome5000(TM). Knockout mice lacking this enzyme had a significantly decreased number of circulating lymphocytes and were resistant to inflammation in a wide range of assays modeling processes involved in the development of arthritis and other autoimmune conditions. Because inappropriate activation of lymphocytes is associated with autoimmune disorders, including rheumatoid arthritis, reduction of lymphocyte buildup at sites of disease activity holds promise as a new therapeutic mechanism. Preclinical studies with LX2931 showed a robust and reproducible reduction of inflammation in animal models of arthritis. Additionally, LX2931-treated animals showed a rapid, dose-dependent reduction in peripheral lymphocyte counts.

About Lexicon

Lexicon is a biopharmaceutical company focused on the discovery and development of breakthrough treatments for human disease. Lexicon currently has development programs underway for such areas of major unmet medical need as irritable bowel syndrome, cognitive disorders, and autoimmune diseases. The company has used its proprietary gene knockout technology to discover more than 100 promising drug targets and create an extensive pipeline of clinical and preclinical programs in the therapeutic areas of diabetes and obesity, cardiovascular disease, psychiatric and neurological disorders, cancer, immune system disorders and ophthalmic disease. Lexicon's drug discovery system has been so productive that Lexicon plans to move ten drug candidates into human clinical trials by the end of 2010. This strategic initiative is referred to as the 10to10 program. To advance the development and commercialization of its programs, Lexicon is working both independently and through collaborators including Bristol-Myers Squibb Company, Genentech, Inc. and N.V. Organon. For additional information about Lexicon and its programs, please visit http://www.lexpharma.com.

Safe Harbor Statement

This press release contains "forward-looking statements," including statements relating to Lexicon's clinical development of LX2931 and the potential therapeutic and commercial potential of LX2931. This press release also contains forward-looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon's ability to successfully conduct clinical development of LX2931 and preclinical and clinical development of its other potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Factors Affecting Forward-Looking Statements" and "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2006, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

Lexicon Pharmaceuticals, Inc.
http://www.lexpharma.com

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