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Pivotal Phase III Data Published on Oral BG-12 (Dimethyl Fumarate) in Multiple Sclerosis

Relapse rates significantly reduced versus placebo at 2 years (Sept. 20)

Biogen Idec, based in Weston, Mass. has announced that results from its two pivotal clinical trials evaluating oral BG-12 (dimethyl fumarate) for the treatment of multiple sclerosis (MS) were published in the September 20 issue of the New England Journal of Medicine (NEJM).

In the phase III DEFINE and CONFIRM studies, dimethyl fumarate 240 mg, administered twice daily (BID) or three times daily (TID), demonstrated significant and clinically meaningful reductions in MS relapses and in brain lesions in patients with relapsing-remitting multiple sclerosis (RRMS) compared with placebo, as well as a benefit in slowing the progression of the disease.

DEFINE was a 2-year global study that evaluated dimethyl fumarate (240 mg BID or TID) compared with placebo in patients with RRMS. Both dimethyl fumarate BID and TID met the study’s primary endpoint by significantly reducing the proportion of patients who relapsed by 49% and 50% (P < 0.0001 for both; reported in NEJM as P < 0.001 because of the journal’s requirement that P values smaller than 0.001 be reported as P < 0.001), respectively, at 2 years compared with placebo. Both dosing regimens also met all secondary endpoints in the study.

Like DEFINE, CONFIRM was a 2-year global clinical trial that investigated dimethyl fumarate (240 mg BID or TID) versus placebo in patients with RRMS. The study also included glatiramer acetate (20-mg subcutaneous daily injection) as an active reference comparator versus placebo. Both dimethyl fumarate BID and TID met the study’s primary endpoint by significantly reducing the annualized relapse rate by 44% and 51% (P < 0.0001 for both; reported in NEJM as P < 0.001 because of the journal’s requirement that P values smaller than 0.001 be reported as P < 0.001), respectively, versus placebo at 2 years. In addition, both dosing regimens of dimethyl fumarate met all secondary relapse and magnetic resonance imaging (MRI) endpoints in the study. While not statistically significant, dimethyl fumarate showed a clinically meaningful reduction in 12-week confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS).

Dimethyl fumarate, also known as BG-12, is an investigational oral therapy in late-stage clinical development for the treatment of RRMS, the most common form of MS. Dimethyl fumarate is the only investigational compound for the treatment of RRMS that has experimentally demonstrated activation of the Nrf-2 pathway.

For more information, visit the Biogen Idec Web site.

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