LA JOLLA ANNOUNCES POSITIVE INTERIM DATA ON RIQUENT

La Jolla Pharmaceutical has announced positive interim results from its ongoing double-blind, placebo-controlled, randomized, Phase III trial of Riquent, the company's drug candidate for systemic lupus erythematosus.

The study is designed to assess the ability of Riquent (abetimus sodium) to prevent or delay the time to renal flare in lupus patients with a history of renal disease and with antibodies to dsDNA. A lupus renal flare is a potentially life-threatening increase in inflammation targeting the kidney. The study is expected to enroll approximately 730 patients total. Equal numbers of patients will be treated with 300 mg per week, 900 mg per week or placebo for 12 months.

The recent analyses assessed the impact of treatment with Riquent on reducing antibodies to dsDNA in 101 patients by measuring the percent of antibody reduction from baseline compared with placebo following weekly treatment with 100, 300 or 900 mg of Riquent or placebo. All demographics and baseline characteristics were comparable across dosing groups, and there were 16 to 30 patients per treatment group.

Following eight weeks of treatment, the median percent reduction in antibodies to dsDNA for Riquent-treated patients compared with placebo-treated patients was 36 percent for 100 mg, 48 percent for 300 mg and 66 percent for 900 mg. Antibody reduction for each dose group was significantly better than placebo.

"We are very excited by these results. The higher the dose, the greater the reduction in antibodies to dsDNA, and the relative magnitude of these reductions is greater than we have seen in previous studies, which used lower doses of Riquent," Deirdre Gillespie, president and CEO of La Jolla, said.

Riquent has been well tolerated in all 13 clinical trials, with no serious side effects identified to date, according to the company. Riquent's only known biological activity is the reduction of circulating levels of anti-dsDNA antibodies. Although clinical benefit has not yet been proven, Riquent treatment has significantly reduced these antibody levels in all clinical trials where they were measured.