Vidofludimus is a new drug treatment under investigation for relapsing remitting, secondary progressive and primary progressive multiple sclerosis (MS). It is taken as a tablet once daily.
Vidofludimus for relapsing remitting MS: Phase III
Vidofludimus for secondary progressive MS: Phase II
Vidofludimus for primary progressive MS: Phase II
- Vidofludimus reduces the activity of T-cells and B-cells, which are types of white blood cell involved in the immune response that damages the myelin coating of nerves.
- In relapsing remitting MS, vidofludimus reduced the number of new active lesions on MRI.
- The most common side effects in a clinical study were hair thinning, fatigue, rash and cystitis (urinary tract infection).
Vidofludimus blocks an enzyme (dihydroorotate dehydrogenase, DHODH) which is essential for the growth of activated T-cells and B-cells, white blood cells involved in the immune response that damages the myelin coating of nerves in the brain and spinal cord.
Vidofludimus has a similar mechanism of action to Aubagio (teriflunomide) but is expected to have a more targeted effect, reducing the risk of side effects.
Vidofludimus is taken as a tablet, once daily.
In the phase II Emphasis study, 210 people with relapsing remitting MS took one of two doses of vidofludimus or placebo for 24 weeks. The main measure was the number of new active lesions seen on MRI. Vidofludimus significantly reduced the number of lesions compared to placebo.
ENSURE I and 2 – vidofludimus compared to placebo, in relapsing remitting MS
These identical phase III studies will recruit 2100 participants with relapsing remitting and active secondary progressive MS. One half will take vidofludimus and the other half placebo for 18 months. The main measure of these studies is the time to first relapse. Additional measures include worsening of disability, lesions visible on MRI scans, cognition and loss of brain volume.
Estimated completion date October 2024.
Further details of ENSURE 1
Further details of ENSURE 2
CALLIPER – vidofludimus compared to placebo, in secondary and primary progressive MS
This phase II study is recruiting 450 participants with primary or secondary (active or non-active) progressive MS. One half will take vidofludimus and the other half will take placebo for approximately 6 months. The main aims of the study are to assess the effect of vidofludimus on brain volume change and on disability progression, measured as worsening of disability which persists for six months. The study will also monitor safety and tolerability of vidofludimus.
Estimated completion date April 2024.
Further details of CALLIPER
The main side effects reported in the phase II clinical trial were: