La Jolla's Riquent to enter dose-ranging study

San Diego, USA-based La Jolla Pharmaceutical says it will initiate a multi-dose clinical study in lupus patients of its drug candidate, Riquent (abetimus sodium), which will evaluate on an ongoing basis the ability of higher doses to further reduce antibodies to double-stranded DNA over the next year.

Antibodies to dsDNA are associated with the deadly progression of kidney disease in lupus that often results in treatment with drugs that have life-threatening side effects and result in increased hospitalization. This study is part of the firm's overall clinical program, that includes an ongoing Phase III clinical trial, to evaluate the use of the drug in preventative and acute settings.

In the multi-dose study, approximately 45 patients, or 15 patients per group, will be treated weekly with 100mg, 300mg or 900mg of Riquent for 12 weeks. The trial design will allow the company to assess the effects of higher doses of Riquent while the study is being conducted. Physicians and patients will be blinded to all data but the company will be able to review results on an ongoing basis. The multi-dose study will use the same dosages that are being evaluated in the ongoing Phase III clinical benefit trial of Riquent where the company is blinded to treatment.