Over two million people worldwide are estimated to suffer from multiple sclerosis (MS), which is the leading cause of neurological disability in young adults, and has a significant impact on the overall quality of life. Currently marketed therapies afford an average reduction in relapse rates of 30% in two-year studies and require frequent injections ranging from daily to weekly.
Data from the extension of a Phase II study to 12 months conducted by Novartis Pharma confirm the significant effects of FTY720, a novel oral medication, for the treatment of patients with relapsing MS. The data, presented at the ECTRIMS/ACTRIMS meeting in Thessalonica, Greece, showed that patient groups taking FTY720 who had experienced a reduction in their annualized relapse rate of more than 50% during the first 6 months of the study compared to placebo maintained this low relapse rate during the subsequent 6-month extension. More than 80% patients who received FTY720 for up to 12 months were free from lesions showing active inflammation on magnetic resonance imaging (MRI) at month twelve irrespective of their FTY720 treatment dose.
In a press release, chief investigator Professor Ludwig Kappos, MD, Department of Neurology at the University Hospital in Basel, Switzerland said "We are excited by these full-year study results confirming the significant effect of oral FTY720 on reducing both clinical relapses and inflammatory disease activity that we first saw during the 6-month placebo-controlled phase of the study. FTY720 appeared to be well tolerated; there were no complications during the extension as compared to the 6-month placebo-controlled phase.
According to the press release, oral FTY720 has a novel mode of action different from all available therapies. It reversibly sequesters lymphocytes away from blood and susceptible target organs such as the central nervous system (CNS), thereby reducing neuroinflammation in MS. FTY720 has been developed by Novartis Pharma and licensed from Mitsubishi Pharma Corporation.
Based on the positive results of the Phase II study conducted at 32 centers in 11 countries (Europe and Canada), Novartis is in discussions with regulatory authorities about the FTY720 Phase III program, which is expected to be launched by the end of 2005.