Atacicept enters Ph II RMS evaluation

Merck Serono, the pharmaceuticals division of Germany's Merck KGaA, and its partner, USA-based ZymoGenetics, have initiated a Phase II trial to evaluate the safety and efficacy of atacicept in patients with relapsing multiple sclerosis. The companies noted that atacicept has the potential to complement existing MS drugs by offering a novel mode of action and convenient administration.

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 the drug in reducing central nervous system inflammation in subjects with RMS as assessed by frequent MRI measures. Around 300 RMS patients will be randomly assigned to receive one of three subcutaneous doses of atacicept or placebo for 36 weeks and will be followed up until week 48. The firms are developing the agent as a potential drug for autoimmune diseases such as systemic lupus erythematosus, lupus nephritis, rheumatoid arthritis and MS, as well as B-cell malignancies.