FTY720, a novel oral medication for the treatment of multiple sclerosis (MS) has reduced the rate of clinical relapses by more than 50% and inflammatory disease activity as measured by magnetic resonance imaging (MRI) by up to 80% over six months compared to placebo, according to a phase II data presented at the 15th European Neurological Society (ENS) meeting in Vienna. FTY720 has been developed by Novartis Pharma and licensed from Mitsubishi Pharma Corporation.

Benefits of FTY720 therapy were seen as soon as after two months of treatment and continued to increase over the six month treatment period compared to placebo. Over 90% of patients completed the study.

"FTY720 has shown a significant and consistent effect on both clinical relapses and MRI measures in just six months. With its novel mode of action and the added benefit of an oral formulation taken once daily, further clinical development of FTY720 might have a major impact on the way we treat MS in the future. We hope that the magnitude of benefits shown in phase II will be confirmed in the larger scale phase III study program," said Professor Ludwig Kappos, Department of Neurology, University Hospital, Basel, Switzerland.

Based on the positive Phase II study results, Novartis is currently discussing with regulatory authorities the FTY720 Phase III program which is expected to be launched in the fourth quarter of 2005 involving centres in North America and Europe.

FTY720 is a once-daily oral medication with a novel mode of action offering the potential of an innovative approach to MS treatment. It is the first sphingosine-1-phosphate (S1P) receptor modulator.