Fingolimod was the first oral tablet approved for people with relapsing-remitting MS. It has shown improved outcomes in comparison with placebo or injectable interferons.
However, one side effect of fingolimod is that it can cause the heart to slow down or beat irregularly after the first dose, so recipients have to be monitored in hospital for at least six hours after taking it.
As a result, investigators have been looking at ways to reduce the side effects of fingolimod while retaining the beneficial effects.
Previous pre-clinical and phase I studies have shown that a new fingolimod-like drug called amiselimod shows less side effects on the heart compared to fingolimod. Therefore, in this study researchers examined the safety and efficacy of amiselimod in a larger number of people with relapsing-remitting MS.
Researchers recruited 415 people with MS in 84 centres across Europe and Canada, and followed them for 24 weeks. They found that people who were receiving higher doses of amiselimod had lower disease activity on MRI in comparison with placebo, although lower doses did not show any change in comparison with a placebo. Amiselimod was safe, especially in regard to side effects on the heart rate. Therefore, investigators concluded that this drug merits investigation with further drug trials with larger number of participants (phase III).
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