BG-12, a new treatment for MS, shows promise in clinical trials
28th September, 2012
BG-12, the compound dimethyl fumarate, is a drug which has both anti-inflammatory and neuroprotective effects. It has been used for many years as a treatment for psoriasis in Europe and is currently under investigation as a therapy for relapsing remitting MS. Two Phase III clinical trials were published simultaneously last week in the prestigious New England Journal of Medicine.
The first study followed 1417 people with MS from 28 countries over two years. It compared two doses of BG-12 to placebo (dummy tablets) and glatiramer acetate (Copaxone), an alternative treatment for MS. People taking 240mg BG-12 twice a day had a 44% reduction in relapses and a 21% reduction in progression of their disability when compared with placebo.
The group taking BG-12 three times a day had a greater response, with relapses reduced by 51% and disability progression reduced by 24%. New or active brain lesions as seen on magnetic resonance imaging (MRI) were also reduced. Although the study was not designed to specifically compare BG-12 to glatiramer acetate, BG-12 performed better against relapse rates and disease activity on MRI. Minor side effects, such as flushing and gastrointestinal events were seen in the group on BG-12 treatment.
The second study compared the same two doses of BG-12 to placebo in 1234 people with relapsing remitting MS. This Phase III clinical trial looked at the proportion of people who had relapsed or confirmed disability progression by the end of the two year study period. The proportion of participants who had a relapse was lower in the two BG-12 treatment groups than in the placebo group (27% with BG-12 twice a day and 26% with BG-12 three times a day vs. 46% on placebo). The risk of disability progression was reduced by 34% and 38% in the treatment arms compared to placebo. The relapse rate and activity of brain lesions were also reduced over the 2 years in both treatment groups.
The potential registration of BG-12 as a treatment for MS in Australia is currently under review by the Therapeutic Goods Administration (TGA). MSRA welcomes new treatments that have undergone rigorous clinical testing as a way of giving people with MS more options in reducing the impact of the disease on their lives.