Biotech Values

[mcbio]

LXRX - Phase 2 RA candidate

LXRX is also taking on RA by inhibiting an apparently novel target known as S1P Lyase. See: http://finance.yahoo.com/news/Lexicon-Initiates-Phase-2-prnews-1965368064.html?x=0&.v=1

Lexicon Initiates Phase 2 Clinical Trial of LX2931 in Patients With Rheumatoid Arthritis
- Oral Drug Candidate Inhibits S1P Lyase, a New Target for Autoimmune Disease
- Pathway Proven Important in Regulating Immune System
- Lexicon's Third Drug Candidate in Phase 2 Development

THE WOODLANDS, Texas, Aug. 4 /PRNewswire-FirstCall/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX - News), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced today 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. For more information about Lexicon's clinical development programs, please visit www.lexpharma.com.