Merck initiates Phase II trial of Atacicept in RMS patients
Merck KGaA announced that its Merck Serono division and ZymoGenetics, are initiating a Phase II clinical trial to evaluate the safety and efficacy of atacicept in patients with relapsing multiple sclerosis (RMS).
"This trial with atacicept underlines Merck Serono's long-term commitment to patients with multiple sclerosis. Atacicept has the potential to complement existing MS drugs by offering a novel mode of action and convenient administration," said Dr Anton Hoos, Head of Global Development at Merck Serono.
Dr Nicole Onetto, Senior Vice President and Chief Medical Officer of ZymoGenetics, said, "Patients with multiple sclerosis need more treatment options. 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, multi-center 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 be followed up until week 48.