Ponesimod is a tablet being developed for relapsing MS by Janssen Pharmaceuticals.
- Current phase of trial:
- phase 3
- Type of MS:
- Relapsing MS
Find out more about ponesimod
How does ponesimod work?
Ponesimod reduces damage to myelin by altering the behaviour of immune cells, stopping them from entering the brain and spinal cord. It works in a similar way to fingolimod and siponmod which are already licensed.
How is ponesimod taken?
Ponesimod is a tablet taken once a day.
Phase 3 trials
The OPTIMUM phase 3 trial involved 1130 people with relapsing MS. Researchers found that ponesimod reduced relapse rates by 30.5% compared to the licensed treatment teriflunomide (Aubagio). They also found that ponesimod was more effective than teriflunomide at improving fatigue symptoms, reducing the number of active lesions on MRI scans and reducing brain atrophy. There was no significant difference in the rate of disability progression.
The POINT phase 3 trial planned to test if ponesimod can reduce relapse rates for people who are already taking Tecfidera (dimethyl fumerate) but have active relapsing MS. The trial was terminated in 2020 due to low recruitment.
A 2011 phase 2 trial involved 464 people with relapsing MS. Ponesimod signficantly reduced the number of new active lesions and the frequency of relapses over 24 weeks compared with placebo.
A 48 week extension study found that ponesimod reduced both MRI activity and relapse rates for peole with relapsing MS.
What are the side effects of ponesimod?
The most frequent side effects reported for ponesimod were shortness of breath, high blood pressure and increased levels of certain molecules in the liver.
How does ponesimod compare with current therapies?
The OPTIMUM phase 3 trial compared ponesimod to teriflunomide Ponesimod reduced relapse rates by 30.5% compared to teriflunomide. It was also was more effective than teriflunomide at improving fatigue symptoms and MRI activity, and at reducing brain atrophy.
When is ponesimod likely to become available?
In March 2021 the US Food and Drugs Administration approved ponesimod as a treatment for people with relapsing MS based on the results of the OPTIMUM trial.
In August 2021, the Medicines and Healthcare Products Regulatory Agency (MHRA) granted a UK licence to ponesimod for the treatment of people with active relapsing forms of MS. But, the National Institute for Health and Care Excellence (NICE) has made a provisional decision not to recommend ponesimod be made available on the NHS in England and Wales. They’ve stated this is due to it not being cost-effective.
In Scotland, separate appraisals are carried out by the Scottish Medicines Consortium (SMC), and a decision on ponesimod is expected in November 2021.