BG-12 (dimethyl fumarate)

Parent company: Biogen Idec

• Oral medication taken daily.
  
  
• This drug may have a distinct dual mechanism of action. First, it is an immunomodulator with anti-inflammatory properties. This induces anti-inflammatory cytokines (small proteins that may stimulate or inhibit the function of other cells) and appears to suppress damaging macrophage cell activity. Second, BG-12 may also have neuroprotective effects. This is due to its activation of a substance that is critical for resistance to cellular damage (from what is termed "oxidative stress") as well as for normal immune function. BG-12 is initially being studied in RRMS.
  
  
• The Phase III DEFINE study, which compared two doses of BG-12 against placebo in 1,200 patients, was completed in February 2011. After two years of treatment, BG-12 reduced relapses by 49 percent, and decreased the rate of disability progression by 38 percent.
  
  
• The Phase III CONFIRM study, completed in September 2011, tested two dose levels against Copaxone and placebo in 1,232 patients. The primary measure was a reduction in relapse rate.
  
  
• A Phase III continuation study of 1,700 patients who participated in the DEFINE and CONFIRM studies will evaluate the long-term safety profile of BG-12 as well as its long-term efficacy on clinical outcomes, MRI scans, and quality-of-life. The study will be completed in June 2013.
  
  
• The Phase II EXPLORE trial is evaluating oral BG-12 as a combination therapy for patients who continue to experience disease progression despite ongoing treatment. It will evaluate the safety and tolerability of BG-12 when administered in combination with interferons or Copaxone to 100 people (who continue to have evidence of disease activity despite receiving consistent monotherapy for at least one year). Efficacy endpoints will also be assessed in a subset of participants. The study began in May 2010 and will be completed in October 2011.
  
  
• Trials to date indicate that BG-12 is safe and that its overall tolerability improves with continued use. Side effects include skin flushing and gastrointestinal symptoms.