LA JOLLA EXPANDS TRIAL OF RIQUENT FOR LUPUS KIDNEY DISEASE

La Jolla Pharmaceutical has reactivated enrollment in its Phase III trial of Riquent (abetimus sodium) for the treatment of lupus renal disease. To date, the company has activated 30 sites, 21 in the United States and nine in Asia. In addition to these sites, the company is expanding the study to Europe and Mexico. A total of approximately 600 patients from about 100 clinical sites in more than 10 countries will be enrolled in this study.

The current study follows a review of the Riquent new drug application by the FDA, which informed the company the drug was approvable subject to the successful completion of another Phase III clinical benefit trial.

The trial is a double-blind, placebo-controlled, randomized trial designed to gain FDA approval for Riquent as a treatment for lupus renal disease, a leading cause of sickness and death in lupus patients. The trial protocol specifies two doses of Riquent that are higher than those used in previous studies. Previous research indicates that higher Riquent doses may further reduce levels of antibodies to double-stranded DNA, which are believed to cause lupus renal disease.