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news.Novartis has reported new positive Phase III results, which showed that 80-83% of patients taking FTY720, an investigational oral compound for relapsing-remitting multiple sclerosis, remained free of relapses during the one-year study compared to 69% of those on interferon beta-1a, an established standard of care.
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According to Novartis, these data reinforce previous results from the Transforms study announced in December 2008 showing that the relapse rate at one year was 52% lower in patients taking FTY720 0.5mg than with interferon beta-1a, or Avonex (0.16 versus 0.33 respectively). In Transforms, FTY720 was generally well-tolerated with 87% of FTY720 patients completing the study on treatment.
The relapse rate with FTY720 1.25mg was 38% lower than with interferon beta-1a (0.20 vs. 0.33, both p<0.001). Full results will be submitted to a peer-reviewed journal in the next few months, with regulatory submissions planned in the US and EU at the end of 2009, the company said. The company has also reported longer-term results from an ongoing open-label Phase II extension study (n=155). This showed continued low relapse rates after four years of treatment with FTY720, with no significant change in the safety profile from three to four year. Jeffrey Cohen, lead investigator of the Transforms study, said: "Transforms is the first Phase III clinical trial to show that oral fingolimod may provide patients with an alternative choice to currently available medications for treating relapsing-remitting multiple sclerosis."