Current phase of trial: Stage 3
How does siponimod work?
Siponimod works in a similar way to the licensed treatment fingolimod.
It traps certain types of immune cell (called B and T cells) in the body's lymph nodes. This stops them from getting into the brain and spinal cord, where they could cause damage to the protective myelin coating around the nerves.
How is siponimod taken?
Latest siponimod research
The EXPAND trial
This phase 3 trial involved 1,651 people with secondary progressive MS.
Top line results from the EXPAND trial were announced at a scientific conference in September 2016 and published in The Lancet journal in 2018.
Siponimod was found to reduce risk of disability progression by 21% compared with placebo. Only 26% of people on siponimod experienced a worsening of disability while on the trial, compared to 32% who took a placebo (dummy drug). Siponimod also significantly reduced the rate of brain atrophy (shrinkage) and the number of relapses people experienced.
The results of this trial are a positive step forward in treatments for secondary progressive MS, but we still need to know more about the safety of siponimod and who will benefit from it.
On average, people participating in the trial had only had secondary progressive MS for less than 4 years. And some still had relapses during the trial. It’s still unclear whether siponimod can help people who've had secondary progressive MS for many years.
Generally, siponimod was well tolerated, but like other DMTS, some people did experience side effects. These ranged from minor side effects like runny noses, to more serious conditions, like high blood pressure and low white blood cell count.
The BOLD trial
This phase 2 trial involved 188 people with relapsing MS and tested different doses of the drug. Siponimod was found to reduce relapse rates compared with placebo, and MRI scans also showed that siponimod reduced the number of brain lesions.
Long-term results were announced in July 2016. Novartis reported siponimod benefits were maintained at two years, particularly in people taking the higher doses of the drug (10 mg, 2 mg and 1.25 mg).
What are the side effects of siponimod?
Side effects reported in the phase 2 study included headache, slowing of heart rate, dizziness and nose and throat infections.
When is siponimod likely to be available?
In 2019, the US Food and Drug Administration (FDA) approved siponimod as a treatment for adults with relapsing forms of MS, active secondary progressive MS, and clinically isolated syndrome.
This is the first licensed treatment for secondary progressive MS in over 15 years.
Siponimod was licensed by the European Medicines Agency (EMA) on Monday 20 January 2020. It's now being assessed by bodies across the UK. We're expecting a decision by mid 2020. Find out more about the journey from lab to pharmacy shelf.