Monday, 18 April 2011

BG12 - the last of the 5 oral MS therapies in phase 3 is positive

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. Medscape press release

"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."

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