FDA special protocol assessment received for atacicept

The agreement is one of two clinical studies intended to form part of the application for marketing authorization. The randomized, double-blind placebo-controlled multi-center clinical trial will be conducted at sites in North America, Europe, Latin America and Asia. Approximately 200 patients with active lupus nephritis will be enrolled in this trial, aimed at demonstrating the efficacy and safety of atacicept as compared to placebo.

Nicole Onetto, senior vice president and chief medical officer of ZymoGenetics, said: “Together with Merck Serono, we concluded that a special protocol assessment (SPA) provided the clearest path to ensure that this trial will support the application for atacicept marketing authorization. We’re pleased to have reached agreement with the FDA about the design of this study and plan to begin enrolling patients in the fourth quarter of 2007.”

The FDA evaluates the design of clinical trials intended to form the basis of an efficacy claim to support a new drug application. The SPA provides a binding agreement between the FDA and a company that the study design, trial size, endpoints and data analyses plan, are acceptable to the FDA and are adequate to support a license application for marketing in the US.

ZymoGenetics and Merck Serono are developing atacicept as a potential treatment for autoimmune diseases and B-cell malignancies. Merck Serono is the study sponsor, however ZymoGenetics will operationally conduct the lupus nephritis study. The companies plan to conduct a second study in patients with general systemic lupus erythematosus, for which the SPA review process is ongoing.