Vidofludimus calcium


Other names: IMU-838

Summary

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

Phase 3

Vidofludimus for secondary progressive MS: Phase II

Phase II

Vidofludimus for primary progressive MS: Phase II

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).

How does vidofludimus work?

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. The drug is thought to reduce inflammation around the nerves.

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.

How is vidofludimus taken?

Vidofludimus is taken as a tablet, once daily.

Vidofludimus research

What are the results so far?

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.

What further research is planned?

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

Study website

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, but an interim analysis published in February 2024 indicated that people in the study taking vidofludimus calcium had 22.4% reduction in serum neurofilament levels. Neurofilaments are used as an indicator of nerve damage, so the researchers interpret this as showing that vidofludimus calcium acts in a neuroprotective way.

Further details of CALLIPER

Side effects

The main side effects reported in the phase II clinical trial were:

References
Fox RJ, et al.
A double-blind, randomized, placebo-controlled phase 2 trial evaluating the selective dihydroorotate dehydrogenase inhibitor vidofludimus calcium in relapsing-remitting multiple sclerosis
Ann Clin Transl Neurol, 9: 977-987.
Full article (link is external)
Muehler A, et al.
Vidofludimus calcium, a next generation DHODH inhibitor for the treatment of relapsing-remitting multiple sclerosis.
Mult Scler Relat Disord. 2020 Aug;43:102129.
Full article (link is external)
Fox, RJ et al.
Impact ofVidofludimus Calcium on Serum Neurofilament in Progressive MS: Data from the CALLIPER Interim Analysis
ACTRIMS: poster 2024
Poster pdf (link is external)
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