LJP Lupus Drug Clears Third Phase II Study

A new appoach to the treatment of systemic lupus eryhthematosus has shown itself to be safe and provoke a positive dose response in a Phase II study. La Jolla Pharmaceutical's LJP 394 is designed to reduce the levels of double-stranded DNA antibodies which are belived to be responsible for lupus nephritis, a principal cause of morbidity and mortality in lupus patients.

Lupus is a chronic autoimmune disease of connective tissue, usually affecting the skin and various internal organs. Typical symptoms include a red, scaly rash, arthritis and progressive kidney damage. In severe cases, the heart, lungs and brain can be affected by repeated inflammation followed by scar tissue formation. The disease in its various forms affects 500,000 people in the USA and there are 16,000 new cases each year. Nine out of 10 lupus patients are women.

LJP 394 was administered to 58 patients with mild lupus symptoms in order to explore its activity and safety at various doses and frequencies of administration. Apart from placebo, nine treatment groups at three dose levels (1, 10 and 50mg) and three frequencies (once/week, once/2 weeks and once/4 weeks) were assessed. Patients were evaluated for two months prior to dosing, treated for four months and then monitored for a further two months after treatment.