Fingolimod, which is being developed by Novartis, binds to sphingosine 1-phosphate receptors on lymphocytes. The drug effectively ‘traps' lymphocytes in lymph nodes, reducing the number of cells circulating in the bloodstream and thereby lessening nerve inflammation.
Recently released data from a two-year Phase III trial show that fingolimod significantly improved two key disease measures in 1272 patients with relapsing-remitting multiple sclerosis. In the FREEDOMS study, fingolimod reduced annualised relapse rates by up to 60% and cut the risk of disability progression by as much as 32% compared with placebo.
The two doses of fingolimod tested, 0.5mg and 1.25mg once daily, exhibited comparable efficacy. However, investigators observed fewer adverse events at the 0.5mg dose than the 1.25mg dose. The lower dose is likely to be the focus of the drug's approval application.
"FREEDOMS reinforces the potential for fingolimod as a significant breakthrough in the future treatment of relapsing-remitting MS," said study investigator David Bates, Professor of Clinical Neurology at the University of Newcastle upon Tyne. "These results mean that a patient who would have had an attack every three years might expect one only every six to seven years. This, in itself, reduces the degree of disability."
In an earlier one-year Phase III study (TRANSFORMS) in relapsing-remitting multiple sclerosis, fingolimod reduced relapse rates significantly more than interferon beta-1a.
A third pivotal study of fingolimod (INFORMS) is ongoing in patients with primary progressive multiple sclerosis.
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