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news.La Jolla Pharmaceutical has announced positive 12-month interim antibody data from its ongoing double-blind, placebo-controlled, randomized Phase III study of Riquent, for systemic lupus erythematosus.
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Analyses of 12-month interim antibody data in the first 125 patients randomized in the study indicate that for all patients treated with 900mg, 300mg, or 100mg of Riquent per week compared with placebo, there were significantly greater reductions in antibodies to double-stranded DNA.
The data show a dose-response curve for antibody reduction and also show that the 300mg and 900mg 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. The rate at which antibody levels were maximally reduced appeared to be more rapid in the 900mg dose group than in the 300mg or the 100mg dose groups.
Michael Tansey, executive vice president and chief medical officer of La Jolla, said: “Treatment with all doses of Riquent resulted in significant and sustained reductions in antibodies to dsDNA during the entire one-year treatment period. Equally important, antibody levels observed in the placebo-treated patients remained around or above baseline and did not drift lower over time as occurred in the previous phase III study.”