Fingolimod in 2009

showed that disease activity, measured by magnetic resonance imaging or MRI, was reduced by up to 80% compared to placebo, and the rate of relapses dropped by 50%. Patients who continued fingolimod in the following six months maintained the lowered relapse rate, and patients who were switched from placebo to fingolimod dropped their relapse rate by at least 70%.

"These results demonstrate that once-daily oral FTY720 provides a significant and rapid improvement in MRI measures of inflammation, as well as in relapse-related clinical endpoints in patients with relapsing multiple sclerosis," said Chief Investigator Professor Ludwig Kappos, MD, of the Department of Neurology at the University Hospital in Basel, Switzerland. "If the magnitude of benefits shown in this Phase II study are confirmed in the larger-scale Phase III study program, oral FTY720 could represent a major improvement in the way MS will be treated in the future."

Of paramount concern after the Tysabri-PML situation, the safety profile of FTY720 seems relatively mild at this stage (recall that so did Tysabri's when it was in Phase II and III). Most common adverse affects had to to do with respiratory infections and GI issues. There were also increases in liver enzyme activity and blood pressure, though these were asymptomatic. A close eye will certainly be kept on these parameters during Phase III.

Speaking of which, the Phase III study, called FREEDOMS, is massive. It includes over 100 study centers and will ultimately enroll over 2,000 patients worldwide in a 2 year trial.

Yes, 2 years and "currently enrolling" means that the minimum time to market for Fingolimod should be approximately 3 years from now, placing us in 2009. Certainly, this tempers the excitement about this drug for the time being, but it is always encouraging to see a promising therapy progressing to the final stage of trials-- and in this case, potentially delivering the benefit of a once-daily oral therapy with a limited side effect profile and potent disease modifying abilities.
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