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Home Industry News Merck Serono initiates atacicept trial

Merck Serono initiates atacicept trial

13th December 2007

Merck Serono and ZymoGenetics have announced that a new phase II/III clinical trial will be launched investigating the safety and efficacy of atacicept in patients with lupus nephritis, a severe form of systemic lupus erythematosus (SLE).

The trial is being conducted as part of a Special Protocol Assessment agreement with the US Food and Drug Administration and is intended to support forthcoming applications for marketing authorisation.

Merck Serono and ZymoGenetics expect to enroll around 200 patients with the trial to be conducted across 80 sites worldwide.

The objective of the study is to evaluate the efficacy and safety of atacicept in patients with active lupus nephritis who are also receiving immunosuppressive therapy with mycophenolate mofetil and corticosteroids.

Anton Hoos, Merck Serono’s head of global development, confirmed that the study formed part of the company’s ongoing development programme investigating atacicept in autoimmune and inflammatory disease.

“It underscores Merck Serono’s strong commitment to offering innovative treatment options to patients and their doctors in indications with unmet medical need,” he said.

The kidneys are affected in at least 30 per cent of the estimated 1.5 million people suffering from SLE worldwide.

Last month, Merck Serono and its partner Newron Pharmaceuticals initiated their Motion study which comprised of a new phase III clinical trial of Safinamide in Parkinson’s disease.

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