Biogen Idec starts BG-12 phase III trial

Biogen Idec has announced the start of phase III clinical studies investigating the administration of oral fumarate BG-12 in patients with relapsing-remitting multiple sclerosis (MS).

The two worldwide studies, Define (determination of the efficacy and safety of oral fumarate in relapsing-remitting MS) and Confirm (comparator and an oral fumarate in relapsing-remitting MS) will study the effect of BG-12 on clinical relapse, the progression of symptoms and MRI measures.

Data from previous trials suggest BG-12 is an immunomodulator with a new means of action, combining anti-inflammatory and cytoprotective features.

Ralf Gold, professor and chair of the department of neurology, said: “Earlier studies of BG-12 support its potential as an oral therapy for MS.

“The extensive phase III clinical programme of BG-12 will provide greater understanding of its promise in MS.”

He added that there is currently an unmet need for orally-administered pharmaceuticals for the treatment of MS.

In November 2006, Biogen Idec reported that it would be making Avonex (Interferon beta-1a) available in Japan. The compound is the most prescribed MS drug available worldwide.

The company stated that Avonex provides efficacy and convenient dosing regimen that enables patients to stay with this treatment option in the long-term.