Biogen Idec licensed the exclusive worldwide rights to develop and market BG-12 from Swiss based privately held pharmaceutical company Fumapharm.
The study achieved its primary endpoint, demonstrating that treatment with BG-12 led to a statistically significant reduction in the total number of gadolinium-enhancing brain lesions as measured by MRI with six months of treatment versus placebo. These data were presented at the annual meeting of the European Neurological Society in Lausanne, Switzerland.
“We are encouraged that these phase II data demonstrate that BG-12 may be a promising oral therapy to treat MS. As part of our ongoing commitment to MS patients, we are working with regulatory authorities to determine the next steps in the development of this program,” said Dr Burt Adelman, executive vice president, Development, Biogen Idec.
This phase II multi-center, double-blind, placebo-controlled, dose-ranging study enrolled 257 patients at sites in 10 countries in Europe. Patients were randomized to receive placebo or BG-12 at 120mg, 360mg, or 720mg per day for six months.
The patient group treated with 720mg of BG-12 per day had a 69% reduction in the mean number of gadolinium-enhancing lesions versus placebo as measured monthly from weeks 12 to 24 of the study. The 720mg dose group also had a 48% reduction in newly enlarging T2-hyperintense lesions. BG-12 therapy was also associated with a trend towards reduction in relapse rate.
However, the results of the 120mg and 360mg BG-12-treated groups were not statistically significant versus placebo. Patients were followed for an additional six months as part of a dose-blinded safety extension study.