Siponimod

Siponimod (also known as BAF312) is a tablet being developed for secondary progressive MS by Novartis Pharmaceuticals.

Current phase of trial: Phase 3

Type of MS: Secondary progressive MS

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.

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How is siponimod taken?

Daily tablet

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Latest 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. Siponimod was found to reduce risk of disability progression by 21% compared with placebo.  Siponimod also significantly reduced the rate of brain atrophy (shrinkage) and the number of relapses people experienced.

While these results have yet to be published, they represent real progress towards finding a disease modifying therapy for people with secondary progressive MS. 

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Earlier research

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).

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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.

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When is siponimod likely to become available?

In 2016 Norvatis, who developed simponimod, announced that they will finish analysing the results and publish them in a scientific journal. They are also planning to consult with health authorities on the next steps for this treatment.

For siponimod to be available for people with secondary progressive MS, the phase 3 trials results will need to be submitted to the European Medicines Agency to begin the licensing process.

We will keep you updated on the progress of siponimod.

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