Pharmaceutical Business review

Merck announces initiation of Phase II multiple sclerosis trial

The four-arm randomized, double blind, placebo-controlled, multi-center study will evaluate the safety and efficacy of atacicept in patients with relapsing multiple sclerosis (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.

Anton Hoos, head of global development at Merck Serono, said: “Atacicept has the potential to complement existing multiple sclerosis drugs by offering a novel mode of action and convenient administration.”