BG00012 (BG 12; fumarate; fumaric acid esther)
Parent company: Biogen Idec
- Oral medication taken daily.
- This drug may have a distinct dual mechanism of action. It is an immunomodulator with anti-inflammatory properties that appears to suppress macrophage activity (immune cells that stimulate lymphocytes) as part of its anti-inflammatory activity. It also may have neuroprotective effects; this is due to its activation of a substance that is critical for resistance to cellular damage from what is termed "oxidative stress," as well as for normal immune function. It is being studied in RRMS.
- Ongoing studies continue to show a reduction in the formation of new gadolinium-enhanced lesions compared to placebo, a significant reduction in relapse rate, and decreased disease activity on MRI
- The Phase III DEFINE and CONFIRM studies continue to recruit participants. The DEFINE study is comparing two doses of BG00012 against placebo in 1,011 patients; the CONFIRM study is testing two levels of the drug against Copaxone and placebo in 1,232 patients.
- Trials to date indicate that the drug is safe, and that its overall tolerability improves with continued use. A long-term Phase III efficacy and safety study is enrolling approximately 1,700 individuals who participated in earlier trials.