BG00012 (BG 12; fumarate; fumaric acid esther)
- Parent company: Biogen Idec.
- Oral medication taken daily.
- This drug is an immunomodulator with anti-
inflammatory properties; may potentially have neuroprotective effects. This drug is being studied in RRMS.
- In a Phase 2b safety-extension study using three dose levels, the highest dose reduced the formation of new gadolinium-enhanced lesions by 69 percent compared to placebo, reduced relapse rate by 58 percent, and decreased disease activity on MRI; over the 48-week period, BG00012 was reported to be safe and tolerable.
- The Phase III DEFINE and CONFIRM studies are now recruiting. The DEFINE study will compare two doses of BG00012 against placebo in 1,011 patients. The CONFIRM study will test two levels of the drug against Copaxone and placebo in 1,232 patients.