Genelabs, FDA Agree on Design for New Trial

Genelabs Technologies announced it has reached agreement with the FDA on a special protocol assessment (SPA) for a Phase III clinical trial of Prestara for the treatment of systemic lupus erythematosus.

The SPA documents the FDA's agreement that the design and planned analyses of the study adequately address objectives in support of a new drug application (NDA) submission, according to the company. The FDA has indicated to Genelabs that a positive outcome to the proposed new Phase III study in addition to evidence of efficacy from previous trials of Prestara (prasterone) and an overall positive risk-benefit assessment would in principle meet the agency's standards for NDA approval.

The company had previously sought approval of the drug as a treatment for bone mineral density loss in lupus patients, and the FDA replied to its NDA submission with an approvable letter in 2002.

"FDA has earlier designated the Prestara NDA approvable, and a previously completed Phase III clinical trial of Prestara in lupus has been agreed by the FDA as being positive, adequate and well-controlled," President and CEO James Smith said. "Now, having reached agreement with the FDA on an SPA for a new Phase III trial, we have a clear regulatory pathway for Prestara in the U.S."

The primary endpoint for this randomized, double-blind, placebo-controlled rial will be time to first severe flare. The principal secondary endpoint will be time to first treatment intervention for moderate or severe lupus flare. The study will target enrollment of approximately 500 women with active systemic lupus erythematosus who are receiving standard of care medications such as glucocorticoids, cytotoxic and immunosuppressive agents. Patients will be randomized to receive either 200 mg of Prestara daily or placebo for 12 months.

Prestara contains highly purified prasterone, the synthetic equivalent of dehydroepiandrosterone, a naturally occurring hormone that is the most abundant adrenal hormone in humans.