La Jolla Pharmaceutical Co. has initiated a Phase III clinical trial to demonstrate the safety and efficiency of its drug, LJP 394.
The drug is designed to reduce the levels of antibodies to the double-stranded DNA, which is believed to be responsible for causing the lupus kidney disease.
The company estimated approximately half of the million-plus lupus patients in the United States and Europe have kidney disease, the leading cause of morbidity and mortality in lupus patients.
Lupus, or systemic lupus erythematosus, is an autoimmune disorder in which antibodies and immune cells attack the person’s own tissue as if it was a foreign virus or bacteria, according to WebMD, the medical information Web site. The life-threatening disease usually affects women, and the onset of the disease occurs during their childbearing years.
“(Phase III clinical trial) of several hundred lupus patients is designed to confirm the ability of LJP 394 to treat lupus kidney disease and to be the final clinical trial required for approval of a drug to treat this life-threatening disease,” said Steven B. Engle, chairman and CEO of La Jolla Pharmaceutical Co. “We plan to conduct this double-blind, placebo-controlled trial in 75 major medical centers in North America and Europe.”
Earlier this month, U.S. Food and Drug Administration (FDA) granted La Jolla Pharmaceutical the orphan drug designation for LJP 394.
The Orphan Drug Act of 1983 provides seven years of marketing exclusivity in the United States and enables the company to obtain research funding, tax credits for certain research expenses and a waiver of application user fees when the prevalence of the disease indication occurs in less than 200,000 patients in the United States.
Currently, high doses of corticosteroids and chemotherapy drugs have increased the 10-year patient survival rate, but the toxic effects of these drugs made them the second-leading cause of morbidity and mortality in lupus.
The company plans to enroll about 300 lupus patients to evaluate the potential of LJP 394 to prevent or delay renal flares, thus reducing the need for high doses of corticosteroids and chemotherapy drugs.