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Fingolimod: sustained efficacy over 18 months in patients with relapsing multiple sclerosis

Data from the extension of a Phase II study to 18 months support the significant effects of FTY720 ( Fingolimod ), a novel once-daily oral compound in development for treatment of relapsing-remitting multiple sclerosis.

The data, presented at the American Association of Neurology ( AAN ) Meeting, showed that both patient groups taking FTY720 ( 1.25 mg and 5 mg ) who had experienced more than a 50% reduction in their annualized relapse rate during the study's first six months compared to placebo maintained this low relapse rate during the subsequent 12-month extension.

Currently marketed multiple sclerosis therapies afford an average reduction in relapse rates of only 30% in two-year studies and require frequent injections ranging from daily to weekly.

. In patients who switched from placebo to either the 1.25 mg or 5 mg dosing of FTY720 after six months, the annualized relapse rate was reduced to a similar extent during the subsequent twelve-month extension phase of the study compared to the first six months on placebo.

At month 18, Magnetic Resonance Imaging ( MRI ) scans were performed in a subgroup of patients.
Consistent with what was seen in MRI scans at month six, the vast majority of patients were free from lesions showing active inflammation at month 18.

The most frequently reported adverse events in patients treated up to 18 months were non-serious infections ( colds, influenza ) and headache.
Effects initially seen in the first six months of treatment ( i.e. first dose heart rate reduction, increase in blood pressure, alteration in liver function, mild increase in airway resistance ) did not appear to progress with continued dosing beyond six months.
There were also no unexpected safety findings during the extension phase compared to the six-month placebo-controlled phase.

All patients in the extension study are now continuing with the 1.25 mg dose since both the 5 mg dose, which had a higher rate of adverse events, and 1.25 mg doses were equally effective in reducing disease activity.

Fingolimod binds to the sphingosine 1-phosphate receptor-1 ( S1P1 ) on a proportion of circulating lymphocytes and reversibly traps them in the lymph nodes.
As a result, Finfolimod lowers the number of activated T-cells circulating to the blood stream and central nervous system ( CNS ), which reduces neuroinflammation and myelin damage in the brain and spinal cord.
Under Fingolimod treatment, many components of normal lymphocyte function are unaffected and can be activated as part of the immune response within the lymph nodes and other tissues.

Source: Novartis, 2006