Other names: M2951
Evobrutinib is a new drug treatment under investigation for relapsing remitting multiple sclerosis (MS). It is taken as a tablet once or twice daily.
Evobrutinib for relapsing remitting MS: Phase III
- Evobrutinib interferes with the function of macrophages which have been linked to MS progression and of B cells, a type of white blood cell which is involved in the immune response that damages the myelin coating of nerves
- In relapsing remitting MS, evobrutinib reduced the number of new active lesions on MRI and reduced the yearly relapse rate.
- In phase II studies, the most common side effects were common colds, and increased blood levels of liver enzymes.
Evobrutinib is also being developed as a treatment for rheumatoid arthritis and systemic lupus erythematosus.
How does evobrutinib work?
Evobrutinib inhibits an enzyme called Bruton’s tyrosine kinase (BTK), reducing the activation of B cells and inhibiting immune cells called macrophages which have been linked to MS progression. By inhibiting this enzyme, it is thought that evobrutinib will reduce the damage caused to nerve cells by MS.
How is evobrutinib taken?
Evobrutinib is taken as a tablet, twice daily.
What are the results so far?
In a phase II study, 267 people with relapsing MS took one of three doses of evobrutinib, placebo or Tecfidera. The main measure was the number of active lesions seen on MRI. After 24 weeks of treatment, people taking evobrutinib 75mg once daily had significantly fewer active lesions than those taking placebo. Compared to placebo, there was no significant difference for the other doses of evobrutinib (25mg once daily or 75mg twice daily). Over the 24 week study period there was no significant difference in relapse rate or disability progression for any dose compared to placebo.
What further research is planned?
- EVOLUTION RMS1 and RMS2 - evobrutinib compared to Avonex (beta interferon-1a)
These identical phase III studies will recruit 1860 people with relapsing remitting MS. One half will take evobrutinib and the other Aubagio (teriflunomide) for approximately two years. The main measure for these studies is the number of relapses in a year. Additional measures include worsening of disability which persists for three and six months, lesions visible on MRI scans and participant reported scores for physical function and fatigue.
Estimated completion date September 2023.
Further details of EVOLUTION RMS1
Further details of EVOLUTION RMS2
In the phase II study, the most common side effects were colds, and increases in blood levels of liver enzymes which returned to normal levels when treatment was stopped and did not cause any symptoms.
- Multiple Sclerosis Journal 2018; 24 (2_Suppl), Abstract 322. Summary Primary analysis of a randomised, placebo-controlled, phase 2 study of the Bruton’s tyrosine kinase inhibitor evobrutinib (M2951) in patients with relapsing multiple sclerosis.
- New England Journal of Medicine 2019; 20;380(25):2406-2417. Full article Placebo-controlled trial of an oral BTK inhibitor in multiple sclerosis
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