BG-12 (Fumerate)
How does it work?
BG-12 is an oral version of the drug fumerate. Recent studies have demonstrated it has anti-inflammatory properties, which may be helpful in preventing the inflammation which causes damage in the brain and spinal cord in people with MS. It is able to effect the immune system and there evidence to support the development of BG-12 to treat a number of conditions involving T cells and inflammation.How is it administered?
BG-12 is taken as a tablet once a dayTo what type of MS is it targeted?
Relapsing remitting MSMost recent trial results
The phase II study was designed to evaluate the safety and effectiveness of BG-12 in 257 people with relapsing remitting MS at sites in 10 countries in Europe. Participants received one of three different doses of BG-12 or placebo. The group treated with the higher dose had a 69 percent reduction in lesions compared to placebo. The results of the other doses of BG-12 treated groups showed no difference compared to placebo.Current situation
Biogen Idec is carrying out phase III clinical trials of BG-12 for relapsing remitting multiple sclerosis (MS).The 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) studies will include more than 2,000 people with MS worldwide. These studies will be initiated in the U.S. in late 2008.
DEFINE is a two year trial which will compare the benefits of BG-12 and placebo in people with relapsing remitting MS, (ClinicalTrials.gov Identifier: NCT00420212).
The CONFIRM trial will also investigate the benefits of BG-12 compared to glatiramer acetate (Copaxone) (ClinicalTrials.gov Identifier: NCT00451451).
Both studies will evaluate the effect of BG-12 relapse rate, the progression of disability, and various MRI brain scan measures.
