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BG-12

BG-12 is an experimental new drug treatment for people with relapsing remitting multiple sclerosis (MS) that is taken orally (by mouth).

Other names: BG00012, dimethyl fumarate, fumarate, Panaclar
In development for: Relapsing remitting MS
Status: Phase III
Last updated: June 2010

How does it work?

The mechanism of action is not fully understood, but preclinical studies have suggested that BG-12 may have complex neuroprotective and anti-inflammatory effects.

How is it given?

BG-12 is taken orally as tablets, two or three times per day.

Clinical studies

In a phase II study, different doses of BG-12 were compared to placebo in people with relapsing remitting MS over 24 weeks of treatment. BG-12 significantly reduced MRI-detectable brain lesion activity. A 32% reduction in relapse rate was also observed but could not be considered significant since this measure was not included in the study design.

Further clinical trials

  • EXPLORE - Trial to evaluate oral BG-12 as combination therapy for patients who continue to experience disease progression despite ongoing treatment

    • This phase II open-label study will evaluate the safety and tolerability of BG-12 when administered with beta interferons or glatiramer acetate to 100 people who continue to have evidence of disease activity despite receiving consistent monotherapy for at least a year. Efficacy endpoints will also be assessed in a subset of participants. Details of study in company press release.

  • DEFINE - Efficacy and safety of oral BG00012 in relapsing-remitting multiple sclerosis

    • A phase III, 2 year study comparing two doses of BG-12 and placebo in 1011 participants with relapsing remitting MS. Main measure of the study is relapse rate. The study will also assess the effects of BG-12 on disability progression and disease activity as measured by magnetic resonance imaging (MRI). Further details of this study.

  • CONFIRM - Efficacy and safety study of oral BG00012 with active reference in relapsing-remitting multiple sclerosis

    • This phase III study with 1232 participants is similar to DEFINE, but with an additional group who will be taking glatiramer acetate (Copaxone) for comparison. Further details of this study.

  • Long-term safety and efficacy study of oral BG00012 monotherapy in relapsing-remitting multiple sclerosis

    • An extension study for participants on the DEFINE and CONFIRM studies to assess the long-term effectiveness and safety of BG-12 for a further two years.. Further details of this study.

Side effects and contraindications

The most common side effects were abdominal pain and flushing/feeling hot.

References

Kappos L, et al.
Efficacy and safety of oral fumarate in patients with relapsing-remitting multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phase IIb study
Lancet 2008;372:1463-1472.
Read abstract

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