How does it work?

FTY720 binds to immune cells called lymphocytes and traps them in the lymph nodes. This lowers the numbers of activated T cells circulating in the blood stream and CNS, which reduces inflammation and myelin damage in the brain and spinal cord. 

How is it administered?

FTY720 is taken as a tablet once a day. 

To what type of MS is it targeted?

Relapsing remitting MS, though trials in progressive MS are planned to begin shortly.
 

Most recent trial results

The phase II study was conducted at 32 centres in 11 countries (Europe and Canada) using 281 people with early active relapsing remitting MS split into three groups comparing two doses of FTY720 or a placebo. It evaluated the effect of FTY720 as measured by MRI and relapse rate, as well as safety.

After 6 months the study was extended to 18 months and people receiving the placebo were re-randomised to receive one of the FTY720 drug doses, while people already on the drug continued with their originally assigned treatment.

Both groups taking FTY720 experienced more than 50 per cent reduction in their annual relapse rate during the first 6 months compared to placebo.
A total of 173 people have finished three-years of the study. Continuous use of the drug led to sustained low relapses, with more than 67 per cent of the participants remaining free of relapses after three years. In addition, the inflammatory activity associated with MS, as assessed by MRI scans, remained low, with 89 percent of people with MS free of active brain lesions three years after starting the treatment.
 

Current situation

Novartis has initiated a 24 month phase III trial called FREEDOMS II including more than 2000 people with relapsing remitting MS between ages 18-55 in the US. Enrolment began early in 2006. Final results are not anticipated before 2009. (ClinicalTrials.gov Identifier: NCT00355134)

There is a large phase III trial called TRANSFORMS where the benefits of fingolimod are compared to beta interferon, in a world-wide study including more than 1200 participants. Final results are not anticipated before 2009. (ClinicalTrials.gov Identifier: NCT00340834)

There are also plans for a trial to begin towards the end of 2008 assessing the benefits of FTY720 in progressive types of MS. Information about this trial will be updated here as it becomes available.

 

Side effects

In the initial 6 months side effects such as first dose heart rate reductions, increased blood pressure, alterations in liver function and mild increases in airway resistance were reported. These did not appear to progress with continued dosing after 6 months. Up to 18 months the most frequent adverse effects were non-serious infections (colds, flu) and headache.