Phase II results for Novartis’ FTY720 drug candidate – angling to be the first drug approved as an oral treatment for multiple sclerosis – show that it can provide impressive reductions in relapse rates and inflammation in MS patients over two years.
Novartis has now embarked on a major, 3,000-patient Phase III programme for FTY720 (fingolimod), which works in a different way to current treatments for MS such as the beta interferons and Teva’s Copaxone (glatiramer acetate).
The Phase II results show that up to 77% of patients taking once-daily FTY720 remained free of relapses over two years, updating one-year data that were published in the New England Journal of Medicine earlier this month. Conventional first-line therapies for MS offer an average reduction in relapse rates in the range of 30-35% in two-year studies.
Patients receiving FTY720 also maintained a low rate of inflammatory disease, as measured by magnetic resonance imaging, according to the data presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Madrid.
FTY720 is the first oral sphingosine 1-phosphate receptor (S1P-R) modulator to reach this stage of development, and is licensed by Novartis from Japan’s Mitsubishi Pharma Corp.
The Phase III programme includes the FREEDOMS study comparing FTY720 to placebo over two years in patients with relapsing-remitting MS, as well as TRANSFORMS, which will compare Novartis’ drug with beta interferon therapy.
The Swiss firm is in a race to bring the first orally-active treatment for MS to market, with other players including: Serono with Mylinax (cladribine) in Phase III testing; Teva’s laniquimod (Phase II); Sanofi-Aventis with teriflunomide (Phase II); Biogen Idec/Fumapharm with fumarate drug BG-12 (Phase II); and GlaxoSmithKline/Tanabe with 683699 (Phase II).
The first company to bring an oral MS drug to market is almost certain to have a billion dollar-plus product on its hands, according to Datamonitor, which has predicted that oral products will lead to a doubling of the market for MS treatments, reaching $6 billion a year in 2012.