Twice-daily BG-12 significantly reduced the proportion of patients who relapsed at two years by 49% vs. placebo (p<0.0001). On secondary endpoints, BG-12 significantly reduced annualized relapse rate (ARR) and disability progression by 53% and 38%, respectively, vs. placebo at two years. Mode of action: BG12 or dimethyl fumarate activates the NF-E2-related factor 2 (Nrf2) pathway; this pathway is both anti-inflammatory and neuroprotective.
“Unexpected results for a drug that is not immunosuppressive. The good news is that BG12 comes with a large pedigree of safety from its use in psoriasis. If these results are confirmed this drug is a paradigm changer and will almost certainly have positive effects in a large number of other, neurological and non-neurological, disorders.”
COI: I am a member of the phase 3 clinical trial steering committee.