FTY720: Topline Data from FREEDOMS released today

Novartis released topline data from the Phase III FREEDOMS study comparing 2 doses of FTY720 (Fingolimod) to placebo. Previously, the Phase III TRANSFORMS study comparing rthe same 2 doses of FTY720 to Avonex showed that the novel oral agent had a 38-52% better relapse rate reduction than the injectible interferon.

The current study showed a 54 to 60% relapse rate reduction compared to placebo and also showed 30-32% reduction in disability progression. There was little difference in efficacy between the 0.5 and the 1.25 mg daily dose. As would be expected with this significant clinical data, MRI parameters were significantly better with FTY720 than placebo, though details were not released. There were three deaths, all felt to be unrelated to treatment, 2 in placebo-treated patients and one in a high-dose FTY720-treated patient.

The combination of the TRANSFORMS and FREEDOMS data supports the use of this drug for the treatment of MS. The efficacy places it between the interferons and Tysabri, similar to the efficacy shown by oral cladribine in the CLARITY study. Combining both studies, there have been 3 deaths in patients treated with 1.25 mg and no deaths in those treated with 0.5 mg (out of about 860 patients for each dose in the 2 studies).  In TRANSFORMS, tolerability was a little better for the 0.5 mg dose compared tot he 1.25 mg dose.

I expect that the NDA will be submitted to the FDA by mid-January for the 0.5 mg dose of FTY720.