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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 2011

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.

It is thought that BG-12 changes the balance in the blood of certain types of white blood cells, called helper T cells (or Th cells), and also the chemical messengers (cytokines) that they produce. This results in anti-inflammatory activity. It may also protect the nerve cells in the brain and spinal cord from damage caused by MS by acting on the blood–brain barrier, a membrane that protects the brain tissues from substances in the blood.

How is it given?

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

Clinical studies

  • Efficacy and Safety of BG00012 in MS

    • 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.

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

    • This phase III, 2 year study compared BG-12 taken either 2 or 3 times daily and placebo in more than 1200 participants with relapsing remitting MS. Preliminary data reported that there was a statistically significant reduction in the number of relapses for people taking BG-12 compared to placebo.
    Company press release

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.
    Estimated completion date October 2011. Currently recruiting.
    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.
    Estimated completion date September 2011.
    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.
    Estimated completion date June 2013.
    Further details of this study.

Side effects and contraindications

The most common side effects were headache, fatigue, 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

MacManus DG, et al.
BG-12 reduces evolution of new enhancing lesions to T1-hypointense lesions in patients with multiple sclerosis.
J Neurol. 2011 Mar;258(3):449-56.
Read abstract

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