Biogen has enrolled its first patient in phase III, randomized, double-blind, placebo-controlled trial, designed to evaluate the efficacy and safety of PEGylated interferon beta-1a (BIIB017) in patients with relapsing multiple sclerosis (RMS).
The study will enroll more than 1,200 patients with RMS, between the ages of 18 and 55. The primary objective is to determine the efficacy of PEGylated interferon beta-1a in reducing the annualized relapse rate in patients with RMS at one year.
The study will also examine if, over time, treatment with PEGylated interferon beta-1a can slow disease progression and lead to a decrease in the number of T2 hyperintense brain lesions, commonly seen in MS patients.
Peter Calabresi, Principal Investigator of the ADVANCE trial, said: “Examined in Phase I studies, PEGylated interferon beta-1a was shown to be much longer acting than intramuscular interferon beta-1a and thus offers the possibility of every two or four week dosing without compromising efficacy. This could greatly increase the convenience of this first line class of therapy.