The “calcium” in the active ingredient name of vidofludimus calcium should not fool you. It is by no means a harmless dietary supplement for strengthening bones, but a selective immune cell inhibitor with a relatively good chance of being approved against relapsing forms Multiple Sclerosis. A phase 2 study is also currently underway in progressive MS. The study name of the drug was IMU-838.
More specifically, vidofludimus calcium inhibits this Enzymes Dihydroorotate dehydrogenase (DHODH), which is involved in DNA and RNA synthesis and inhibits the growth of T and B cells. As a result, there are fewer attacks on the myelin layer of the nerve cells and multiple sclerosis is slowed down.
The mechanism of action is known from the drug teriflunomide (Aubagio), which has already been approved for multiple sclerosis. Like teriflunomide, vidofludimus calcium can be taken by mouth once a day.
Differences between vidofludimus calcium and teriflunomide
However, vidofludimus calcium has a different chemical structure and is 2.6 times more potent T-lymphocytes inhibit and has a greater influence on inflammatory messengers. Phase 3 studies and, of course, the approval itself must first show whether this increased effect at the cellular level will result in vidofludimus calcium being classified in a higher efficacy category than teriflunomide. Teriflunomide is in Category 1 efficacy, similar to the interferons, glatiramer acetate and dimethyl fumarate. Another important difference from teriflunomide is the ability to quickly wash out vidofludimus calcium when needed.
In the phase 2 study called EMPhASIS, participants were double-blinded and randomized into three groups:
- a drug group with 30 mg daily,
- a drug group with 45 mg daily and
- a placebo group.
After 24 weeks, there were 6.4 active lesions in the placebo group and only 2.4 active lesions in the 45 mg drug group. This is considered statistically significant. There was no significant difference between the two drug groups.
Overall, the safety profile was favorable, with both serious adverse events occurring Placebo as well as in the drug group in 1% of the subjects. This clears the way for the phase 3 study ENSURE. An interim result should be available at the end of 2024, final results at the end of 2025.
Vidofludimus-Calcium neuroprotektiv?
In addition to these studies on vidofludimus calcium in relapsing MS, there is also a study (phase 2) on progressive MS, because vidofludimus calcium is also said to have a neuroprotective component: the study is called CALLIPER. The first study results can be expected in the second half of 2023, with the final data in 2024. The study lasts a total of 120 weeks. Effects on progression cannot be determined as quickly as, for example, changes in MRI. A possible (slight) neuroprotective effect is also assumed for teriflunomide. It is now crucial whether the neuroprotection proves to be significant in the progressive patient group.