LA JOLLA PROVIDES SUMMARY OF RIQUENT STUDY

La Jolla Pharmaceutical provided a summary of the status of its development program for Riquent (abetimus sodium), its drug candidate for lupus renal disease. A Phase III clinical benefit trial was initiated in August 2004 under a special protocol assessment (SPA) with the FDA. To date, 37 sites in the U.S. have been initiated and 27 patients have enrolled in the study.

In the study, La Jolla has added two higher dose groups, added more patients, restricted the use of immunosuppressive agents, and changed the treatment duration to 12 months. These changes are based on results of the previous Phase II/III and Phase III trials of Riquent.

The primary endpoint, time to renal flare, was refined in order to eliminate the hematuria component, which appears to be less specific for lupus renal disease. Two additional Riquent dose groups were added to the study so that, following the amendment of the SPA, 80 percent of the drug-treated patients will be treated with a higher dose than the 100 mg dose used in the previous Phase III trial. In the drug-treated group, 20 percent of patients will receive 100 mg per week, 40 percent will receive 300 mg and 40 percent will receive 900 mg per week. The trial will evaluate three different doses of Riquent in lupus patients with a history of renal disease, and twice as many patients will be treated with drug as placebo.