Biogen Idec (BIIB) Initiates Phase III Clinical Program of BG-12

January 9, 2007 9:03 AM EST

Biogen Idec (NASDAQ: BIIB) has initiated the Phase III clinical program of BG-12, an oral fumarate in development for relapsing-remitting multiple sclerosis (MS). These studies have been initiated internationally, and Biogen Idec plans to initiate these studies in the U.S. later this year.

Endpoints of both studies include evaluating the effect of BG-12 on measurements of clinical relapse, the progression of disability, and various MRI measures.

Data from a Phase II study designed to evaluate the efficacy and safety of BG-12 were presented at two European neurological medical meetings in 2006. The 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 120 mg, 360 mg, or 720 mg per day orally for six months. The patient group treated with 720 mg of BG-12 per day had a 69% reduction (p<0.001) in the mean number of new gadolinium-enhancing lesions versus placebo as measured monthly from weeks 12 to 24 of the study. The 720 mg dose group also had a 48% reduction (p<0.001) in new or newly enlarging T2-hyperintense lesions at six months compared to baseline. Although the study was not powered to achieve statistical significance for this endpoint, there was a 32% reduction (p=0.272) in relapse rate compared to placebo at the 720 mg dose. The results of the 120 mg and 360 mg BG-12-treated groups were not statistically significant versus placebo on any endpoints.

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