La Jolla Pharma expands Ph III lupus study

The USA's La Jolla Pharmaceutical has updated on the continued progress of an ongoing Phase III study of Riquent (abetimus sodium), its drug  candidate for systemic lupus erythematosus.

The double-blind, placebo-controlled, randomized Phase III study is  designed to assess the ability of Riquent treatment to prevent or delay  the time to renal flare in lupus patients with a history of renal  disease and with antibodies to dsDNA. The event-driven trial is designed  to be completed when 128 renal flares have occurred. Equal numbers of  patients are being treated with 300mg per week, 900mg per week, or  placebo. The pre-specified p value at the end of the study is p<0.05.

To date, 890 patients have been enrolled in the trial. The firm says  current overall renal flare rate continues to be lower than the original  assumption. As a result, in an effort to shorten the time to achieve the  required number of renal flares in the most cost-effective manner, the  company is continuing enrollment beyond the target of 800 patients. The  trial is projected to complete in the second half of 2009.