La Jolla Pharmaceutical Company announced that it would complete enrollment in its Phase III clinical trial of LJP 394 for the treatment of lupus renal disease by November 11, 2002. After the completion of enrollment, study physicians will conduct final patient visits during the next few weeks, at which point the Phase III trial will be finished. Then, the Company will collect and audit final data from the trial sites prior to unblinding and analysis. The Company currently plans to report initial results in early 2003.
Serum samples from approximately 90% of the patients enrolled to date have been analyzed. About 94% of the tested patient samples have high-affinity antibodies to LJP 394. In three previous clinical trials, the percentage of patients who had high-affinity antibodies to LJP 394 was 89%, 90% and 94%, respectively. The Company believes that lupus patients with high-affinity antibodies to LJP 394 are more likely to benefit from treatment with LJP 394.
"As planned, we have reached the targeted number of renal flares in high-affinity patients," said Steven B. Engle, Chairman and Chief Executive Officer. The primary endpoint in the Phase III trial is time to renal flare in patients with high-affinity antibodies to LJP 394, and completion of the trial is based on reaching a targeted number of renal flares. In the samples tested to date, the Company has observed that approximately 90% of patients who experienced a renal flare were high-affinity. Until all patients have been fully evaluated and the resulting data have been extensively analyzed, conclusions should not be drawn regarding the outcome of the study.
The Phase III trial is a randomized, double-blind, placebo-controlled study and is designed to confirm data observed in the Phase II/III trial. In the Phase II/III trial, LJP 394-treated patients who had high-affinity antibodies to the drug had fewer renal flares and fewer treatments with high-dose corticosteroids and/or cyclophosphamide than placebo-treated patients.
Lupus is an autoimmune disease that results in a wide variety of chronic, progressive symptoms including episodes of life-threatening kidney inflammation known as "renal flares." The current standard of care for lupus - treatment with steroids and chemotherapy drugs - can cause severe side effects including diabetes, hypertension and sterility, and may leave patients vulnerable to lethal opportunistic infections. LJP 394 is designed to specifically prevent the production of antibodies responsible for lupus kidney disease without suppressing the normal functions of the immune system.