Genelabs agrees Prestara SPA with FDA

California, USA-based GeneLabs Technologies says that it has reached agreement with the Food and Drug Administration on the details of a Special Protocol Assessment for a Phase III trial of its developmental lupus treatment Prestara (prasterone).

The new study will be run as a randomized, double-blind, placebo-controlled assessment, and is designed to examine the drug's impact on the time to first lupus flare, as defined by SELENA SLEDAI composite criteria. The firm said that it will seek to enroll 500 women with active systemic lupus erythematosus who are currently receiving standard treatment (glucocorticosteroids, cytotoxic agents or immunosuppressive therapy). Participants will be randomized to receive a daily 200mg dose of the drug, or placebo, for a period of 12 months.

The firm added that a positive outcome from the proposed study, conducted as per the SPA protocol, coupled with evidence of the drug's efficacy from previous assessments, would, in principle, meet with the FDA's standards for approval.