The Phase 3 results of another oral agent BG-12 (dimethyl fumarate) in RRMS were reported last week. The top-line results show that 240 mg of BG-12, administered either twice or 3 times daily, met the primary study endpoint, demonstrating a highly statistically significant reduction (P < .0001) in the proportion of patients with RRMS who relapsed at 2 years compared with placebo. Both doses of BG-12 also met all of the secondary study endpoints; (1) reduction in the annualized relapse rate and (2) the number of new or newly enlarging T2 hyperintense lesions, and (3) in new Gd-enhancing lesions on MRI, as well as (4) in the rate of disability progression as measured by the EDSS at 2 years. The overall incidence of adverse events and serious adverse events was similar among the placebo group and both BG-12 treatment groups.
“The mode of action of BG12 is interesting, suggesting that it may be neuroprotective. BG12 may be the ideal drug to use in combination with other anti-inflammatory drugs. Pity about the twice or three times daily dosing regimen.”