Biogen's oral compound BG-12 achieves primary endpoint in multiple sclerosis study

By Elaine Rigoli

Tampa, Fla., May 30 - Biogen Idec and Fumapharm AG announced positive results from a phase 2 study designed to evaluate the efficacy and safety of BG-12, an oral fumarate, in patients with relapsing-remitting multiple sclerosis (MS).

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 a placebo, according to a news release.

"We are encouraged that these phase 2 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," Burt Adelman, Biogen's executive vice president of development, said in the release.

This multi-center, double-blind, placebo-controlled, dose-ranging study enrolled 257 patients at sites in 10 countries in Europe.

Patients were randomized to receive a placebo or BG-12 at 120 mg, 360 mg or 720 mg per day for six months.

The patient group treated with 720 mg of BG-12 per day had a 69% reduction in the mean number of gadolinium-enhancing lesions versus a placebo as measured monthly from weeks 12 to 24 of the study, the release said.

The 720 mg dose group also had a 48% reduction in newly enlarging T2-hyperintense lesions. BG-12 therapy was also associated with a trend toward reduction in relapse rate.

The patient group treated with 720 mg of BG-12 per day had a 32% reduction in relapse rate compared to a placebo; however, the study was not designed to achieve statistical significance for this endpoint.

The results of the 120 mg and 360 mg BG-12-treated groups were not statistically significant versus a placebo. Patients were followed for an additional six months as part of a dose-blinded safety extension study.

Fumapharm is a specialty pharmaceutical company with headquarters in Luzerne, Switzerland.

Biogen is an international pharmaceutical company located in Cambridge, Mass.

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