Novartis has presented more promising data on its investigational oral multiple sclerosis drug fingolimod and says it plans to fill the treatment before the end of the year.

The Swiss firm says that initial results from the two-year Phase III FREEDOMS study show that fingolimod, also known as FTY270, was significantly superior to placebo in reducing both relapses and disability progression in patients with relapsing-remitting MS. The trial met its primary and secondary endpoints for both the 0.5mg and 1.25mg doses, with no significant difference in efficacy between doses.

Novartis said the results builds on previous data from the TRANSFORMS study which showed superior efficacy to the gold standard, interferon beta-1a. Detailed results from FREEDOMS will be presented at a scientific congress in 2010.

In the latest study, FTY720 was generally well tolerated with a lower incidence of adverse events at the 0.5mg dose than 1.25mg and regulatory submissions in the USA and Europe will be sought for the 0.5mg dose in December. Trevor Mundel, head of development at Novartis Pharma, said that fingolimod at the lower dose offers “compelling efficacy on all relevant endpoints compared to both placebo and a standard of care, complemented by extensive safety data”.

He added that FTY720 “has the potential to transform the treatment of this ultimately disabling disease," a view backed by Ludwig Kappos, of the University Hospital in Basel, and principal investigator of the FREEDOMS study. He said the results “confirm the efficacy and safety of fingolimod, and provide important evidence of its effect on disability”. He added that “as an oral therapy, it is clear that fingolimod potentially represents a significant advance in the treatment of MS."

The race to get an oral treatment for MS to market is hotting up and one of the key rivals to FTY720 is Merck KGaA’s cladribine, which was filed with the European Medicines Agency in July. A US submission for the latter is planned shortly.