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Merck Serono and ZymoGenetics Initiate Atacicept Phase 2 Clinical Trial in Relapsing Multiple Sclerosis
Wednesday April 30, 6:00 am ET


SEATTLE--(BUSINESS WIRE)--ZymoGenetics, Inc. (NASDAQ:ZGEN - News), today announced that its development partner Merck Serono, a division of Merck KGaA, Darmstadt, Germany, has initiated a Phase 2 clinical trial to evaluate the safety and efficacy of atacicept in patients with relapsing multiple sclerosis (RMS).


“Patients with multiple sclerosis need more treatment options,” said Nicole Onetto, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. “Our preclinical models have shown biological activity of atacicept in multiple sclerosis and, because of the growing body of supporting data in the literature indicating the importance of B cells and antibodies in the pathology of multiple sclerosis, we believe there is strong rationale for the clinical testing of atacicept in patients with RMS.”

The four-arm randomized, double blind, placebo controlled, multicenter study will evaluate the safety and efficacy of atacicept in patients with RMS over 36 weeks of treatment. The primary objective of the study is to evaluate the efficacy of atacicept in reducing central nervous system inflammation in subjects with RMS as assessed by frequent MRI measures.

Approximately 300 RMS patients meeting the eligibility criteria will be randomly assigned to receive one of three subcutaneous doses of atacicept or placebo for 36 weeks. Patients will have follow-up visits at 48 weeks.

About Relapsing Multiple Sclerosis (RMS)

Multiple sclerosis (MS) is a disease of the central nervous system that can lead to permanent damage of the nerves in the brain and spinal cord. Patients with RMS may experience an attack or series of attacks followed by a complete or partial remission. Permanent disability may be accrued by incomplete recovery from relapses and by neurodegenerative processes, which are more prominent in the later stages of the disease. RMS is the most common form of MS. According to the National MS Society, approximately 400,000 people in the U.S. have MS, and every week about 200 people are diagnosed; worldwide, 2.5 million individuals may have MS.

About Atacicept

Merck Serono and ZymoGenetics are developing atacicept (formerly referred to as TACI-Ig) as a potential treatment of autoimmune diseases, such as systemic lupus erythematosus (SLE), lupus nephritis (LN), rheumatoid arthritis and multiple sclerosis, as well as B-cell malignancies.

Atacicept contains the soluble TACI receptor that binds to the cytokines BLyS and APRIL. These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases such as systemic lupus erythematosus. Current data indicates that levels of BLyS and APRIL are elevated in patients with rheumatoid arthritis, lupus erythematosus, B-cell malignancies and multiple sclerosis. Atacicept has been shown to affect several stages of B-cell development and may inhibit the survival of cells responsible for making antibodies.

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