A recent study of siponimod has highlighted the drug as the first potential therapy to meaningfully delay disability progression in secondary progressive MS (SPMS) patients.
Full results from the phase III EXPAND study of oral, once-daily siponimod in SPMS were published in the peer-review journal The Lancet.
Full data from EXPAND showed that siponimod reduced the risk of three-month confirmed disability progression by a statistically significant 21% versus placebo and 26% at six-month confirmed disability progression.
The results also demonstrated that the drug had beneficial effects on clinical relapses (55%) and MRI disease activity, including a 23% reduction in brain volume loss (brain shrinkage).
However, siponimod did not show a significant difference in the Timed 25-Foot Walk test and MS Walking Scale.
Drug makers Novartis plan to file siponimod for US approval in SPMS in early 2018. Filing for EU approval is planned for later in 2018, pending scientific consultation with EMA.
If approved, siponimod would be the first disease-modifying therapy to delay disability progression in typical SPMS patients, including many who had reached a non-relapsing stage and a high-level of disability.
“Today's published, full EXPAND results show that siponimod can delay disability progression in typical established SPMS patients, where other approaches tested so far have been unsuccessful,” said Professor Ludwig Kappos, University Hospital Basel and Principal Investigator of EXPAND. “These data are all the more impressive when considering that the majority of patients already had advanced disability when starting treatment in EXPAND.”
Source: MS-UK 23/03/18