Remibrutinib is a new drug treatment under investigation for relapsing remitting multiple sclerosis (MS). It is taken as a tablet twice daily.
Remibrutinib for relapsing remitting MS: Phase III
- Remibrutinib reduces the activity of B-cells and regulates immune cells called microglia which have been linked to MS progression.
- Remibrutinib has not been tested in early stage (phase II) clinical trials in MS.
- In early stage clinical trials for other conditions, the main side effects have been headache, common cold, nausea, chest infection, diarrhoea, and fever.
Remibrutinib belongs to a group of medicines called Bruton's tyrosine kinase (BTK) inhibitors.
Bruton’s tyrosine kinase is an enzyme which is essential for the survival and activation of B-cells. B-cells are a type of white blood cell (lymphocyte) thought to be involved in the inflammation caused by MS which causes lesions in the brain and spinal cord and can lead to relapses. The enzyme also regulates immune cells in the brain called macrophages and microglia which have been linked to MS progression.
Remibrutinib blocks the actions of the enzyme and it is thought that this may prevent the MS activity which leads to relapses as well as the longer term damage to nerve cells which causes progression.
Other BTK inhibitors in the MS drug pipeline include evobrutinib, tolebrutinib, fenebrutinib and orelabrutinib.
Remibrutinib is taken as a tablet, twice daily.
No early stage clinical trials of remibrutinib have been carried out in people with MS, but it has been studied as a treatment for other autoimmune conditions, including chronic spontaneous urticaria. In these studies it was found to be well-tolerated with no serious side effects.
REMODEL I and 2 – remibrutinib compared to Aubagio (teriflunomide), in relapsing remitting MS
These identical phase III studies will recruit 1600 participants with relapsing remitting MS and active secondary progressive MS. One half will take remibrutinib and the other half Aubagio (teriflunomide) for up to 2.5 years. The main measure of 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 quality of life.
Estimated completion date April 2026.
Further details of REMODEL 1
Further details of REMODEL 2
The main side effects reported in a phase II clinical trial for chronic skin rash were:
- common cold
- chest infection