Switzerland’s Novartis says a Phase II trial of FTY720 – potentially the first oral drug to treat multiple sclerosis – has shown promising results, reducing the rate of clinical relapses by more than 50% and inflammatory disease activity as measured by magnetic resonance imaging by up to 80% over six months compared to placebo.
The company adds that the 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. In addition, the product appeared to be generally well tolerated, with 92% of patients completing the six-month treatment period. The most frequently reported side effects included colds, nausea and headaches.
However, the company is now not expecting to start the Phase III programme in MS until the fourth quarter of the year after the US Food and Drug Administration asked for an overall safety analysis of the safety database for the drug’s use in transplant patients. Novartis had previously expected to start the late-stage clinical trial programme in the middle of the year.