Clinical Trials - Riquent™

Clinical Trials

Lupus Clinical Trial: For information on the ASPEN Phase 3 study (Abetimus Sodium in Patients with a History of Lupus Nephritis), the ongoing Phase 3 study of Riquent (abetimus sodium), please go to the following website: clinicaltrials.gov

Current Phase 3 Trial: The ASPEN Study

La Jolla Pharmaceutical Company is conducting the ASPEN Study (Abetimus Sodium in Patients with a History of Lupus Nephritis), a placebo controlled Phase 3 clinical benefit trial designed to meet the FDA's requirement that we conduct an additional randomized, double-blind study. The ASPEN study is being conducted under a Special Protocol Assessment ("SPA"). The SPA process is a formal procedure that results in a binding written agreement between a company and the FDA concerning the design of a clinical trial or other study.

The primary endpoint required to confirm efficacy is the time to renal flare for the combined population of patients treated with Riquent with either 300 mg per week or 900 mg per week. Secondary endpoints include time to major SLE flare, a measure of systemic disease activity, and reductions in proteinuria. Proteinuria is an indicator of abnormal renal function and can result from an inability to achieve or maintain complete remission in lupus nephritis. Lack of complete remission increases the risk of additional renal flares as well as the risk of end-stage kidney disease and death.

In contrast with previous clinical trials, the ASPEN study is evaluating higher doses of Riquent. The highest Riquent dose evaluated in previous efficacy studies was 100 mg per week, while the ASPEN study is evaluating 300 mg per week and 900 mg per week. A number of other important enhancements exist in the design of the ASPEN study relative to previous Riquent studies: the number of patients included has been significantly increased, the primary endpoint has been refined, and the use of immunosuppressive agents has been further restricted. In determining how many patients should be enrolled in the ASPEN study, no additional clinical benefit from treatment with doses higher than 100 mg was assumed.

The results of an interim analysis of antibody data in the first 125 patients randomized in the ASPEN study were announced in April 2008. The results indicated that for all patients treated with 900 mg, 300 mg, or 100 mg of Riquent per week compared with placebo, there were significantly greater reductions in antibodies to double-stranded DNA (dsDNA, p < 0.0001). The data show a dose-response curve for antibody reduction and also show that the 300 mg and 900 mg doses appear to be near the top of the antibody-related dose response curve, thus supporting the choice of doses for this study. Antibody levels in the placebo-treated group remained around baseline levels throughout the 12 months.

As of November 24, 2008, 169 sites are active, and 887 patients have been enrolled. The Independent Data Monitoring Board (DMB) has completed four reviews of the safety data and has not indicated any safety issues. The study is event-driven trial designed to be completed when 128 renal flares have occurred. The Company expects the trial to complete in the second half of 2009.