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news.Biotech firm La Jolla Pharmaceutical has initiated a multi-dose clinical study in lupus patients of its drug candidate Riquent designed to treat lupus kidney disease.
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The study will evaluate on an ongoing basis the ability of higher doses of Riquent to further reduce antibodies to double-stranded DNA (dsDNA). 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 company’s overall clinical program, that includes an ongoing phase III clinical trial, to evaluate the use of Riquent in preventative and acute settings.
In the multi-dose study, approximately 45 patients will be treated weekly with 100 mg, 300 mg or 900 mg 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.
“This trial will provide the first data on the ability of higher doses of Riquent to reduce pathogenic antibodies to dsDNA in lupus patients. It will also enable us to continue to evaluate the potential benefit of Riquent for acute treatment of lupus renal flare as well as for preventative care,” said Steve Engle, chairman and CEO of La Jolla. “Published results from our previous clinical trials indicate that a greater reduction in antibodies to dsDNA results in a significantly lower risk of renal flare.”