June 5, 2008 - Merck KGaA announced today that its Merck Serono division and development partner ZymoGenetics, Inc. (NASDAQ: ZGEN) have initiated a Phase II/III trial of atacicept in patients with systemic lupus erythematosus (SLE). This study will evaluate the efficacy and safety of atacicept for the treatment of patients with SLE.
The study is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). A second Phase II/III study in lupus nephritis, a severe form of SLE in which the kidneys are affected, was initiated in December 2007. These two studies are intended to form part of a potential registration package to support worldwide applications for marketing authorization.
“Atacicept has the potential to alter the course of SLE, a complex and devastating disease,” said Anton Hoos, M.D., Merck Serono’s Head of Global Development. “This study should provide us with a basis for assessing treatment outcomes with atacicept.”
The details can be read here.
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