CardiovascularLexicon Initiates Phase 2 Clinical Trial Of LX2931 In Patients With Rheumatoid Arthritis
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced that it has initiated a Phase 2 clinical trial of LX2931 in patients with rheumatoid arthritis. LX2931 is an orally-delivered, small molecule drug candidate that has recently completed Phase 1 testing in normal volunteers. Lexicon also successfully completed a drug-drug interaction (DDI) study of LX2931 with methotrexate in patients with rheumatoid arthritis, with no clinically significant drug-drug interactions observed.
"We believe that, as an oral therapy, LX2931 could have advantages over current biologic therapies in treating patients with rheumatoid arthritis," said Philip M. Brown, M.D., J.D., senior vice president of clinical development at Lexicon. "LX2931 has demonstrated potent anti-inflammatory activity in preclinical models of arthritis and inflammation and, importantly, has been well tolerated in combination with methotrexate, the current standard of care first-line therapy."
LX2931 inhibits sphingosine-1-phosphate (S1P) lyase, an enzyme identified by Lexicon scientists as a promising new target on a pathway associated with regulation of the human immune system. Lexicon has previously shown that genetically "knocking out" or "knocking down" S1P lyase in mice substantially decreased 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.
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 disability from irreversible joint damage. According to the National Institutes of Health, autoimmune disorders affect between 14.7 and 23.5 million people in the United States.
About Lexicon
Lexicon is a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease. Lexicon currently has five drug candidates in development for autoimmune disease, carcinoid syndrome, diabetes, glaucoma and irritable bowel syndrome, all of which were discovered by the company"s research team. The company 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.
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, 2008, 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.