La Jolla Pharmaceutical Company Reports Progress In International Phase 3 Riquent(R) Study

Main Category: Lupus
Also Included In: Clinical Trials / Drug Trials
Article Date: 13 Feb 2008 - 4:00 PST

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La Jolla Pharmaceutical Company (Nasdaq:LJPC) announced significant progress in its ongoing double-blind, placebo-controlled randomized Phase 3 trial of Riquent(R) (abetimus sodium), its drug candidate for systemic lupus erythematosus ("lupus" or "SLE"), including additional safety data on the trial's higher doses.

To date, 607 patients have been enrolled in the study at more than 130 clinical trial sites in 23 countries. Total enrollment in this event-driven trial is targeted for 740 patients and is expected to be complete around the end of the second quarter of 2008. The study requires a specified number of renal flare events to be observed.

The Data Monitoring Board has completed two safety reviews of the study without identifying any safety concerns. To date, more than 350 patients have been treated in the trial with either the 300 mg or 900 mg dose.

"We have made tremendous progress toward the completion of enrollment in the Phase 3 study," said Deirdre Y. Gillespie, M.D., President and CEO of La Jolla Pharmaceutical Company. "We have increased the dose nine-fold and are very encouraged that the data continue to indicate that the 300 mg and 900 mg doses of Riquent are as well tolerated as the 100 mg dose was in our previous studies."

Two interim efficacy analyses are planned in this event-driven trial. The first interim efficacy analysis is now expected in the second quarter of 2008. The second interim efficacy analysis is still expected to occur around the end of 2008.

The Phase 3 study is designed to assess the ability of Riquent treatment to delay the time to renal flare in lupus patients with a history of renal disease and with elevated levels of anti-dsDNA antibodies. A lupus renal flare is a potentially life-threatening increase in inflammation of the kidney due to lupus. A renal flare often requires treatment with immunosuppressive agents which can have severe side effects.

Riquent has received an Approvable Letter and Fast Track status from the Food and Drug Administration, and has received Orphan Drug designation. The current trial is being conducted under a Special Protocol Assessment.

About Riquent

Riquent is being developed to specifically treat lupus renal disease by preventing or delaying renal flares, a leading cause of sickness and death in lupus patients. It is also being studied to assess whether Riquent treatment improves proteinuria, as was observed in previous clinical trials. Proteinuria is an indicator of abnormal renal function. Riquent has been well tolerated in all 14 clinical trials, with no overall difference in the adverse event profiles for Riquent-treated patients compared with placebo-treated patients. Riquent specifically reduces circulating levels of anti-dsDNA antibodies. Increases in these antibodies are associated with an increased risk of renal flare. Although clinical benefit has not yet been proven, Riquent treatment has significantly reduced these antibody levels in all clinical trials in which they were measured.

About Lupus

Lupus (systemic lupus erythematosus) is a chronic, potentially life-threatening autoimmune disease. About 90% of lupus patients are female, and many are diagnosed with the disease during their childbearing years. Approximately 50% of lupus patients have renal disease, which can lead to irreversible renal damage, renal failure and the need for dialysis, and is a leading cause of death in lupus patients. Latinos, African Americans and Asians face an increased risk of serious renal disease associated with lupus. The current standard of care for lupus renal disease often involves treatment with high doses of corticosteroids and immunosuppressive drugs that can cause severe side effects including diabetes, hypertension and sterility, and may leave patients vulnerable to opportunistic infections. To date, no lupus-specific drug has been approved in the U.S.

La Jolla Pharmaceutical Company is dedicated to improving and preserving human life by developing innovative pharmaceutical products. The Company's leading product in development is Riquent®, which is designed to treat lupus renal disease by preventing or delaying renal flares. Lupus renal disease is a leading cause of sickness and death in patients with lupus. The Company has also developed potential small molecule drug candidates to treat various other autoimmune and inflammatory conditions. The Company's common stock is traded on The NASDAQ Global Market under the symbol LJPC.

La Jolla Pharmaceutical Company