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.
How is ponesimod taken?
Ponesimod is a tablet taken once a day.
Phase 3 trials
The OPTIMUM phase 3 trial will test if ponesimod (20 mg) can reduce relapse rates and slow disability progression more effectively than the licensed treatment Aubagio (teriflunomide).
The trial will involve 1,100 people with relapsing MS, and the trial is due to finish in 2019.
The POINT phase 3 trial will test if ponesimod can reduce relapse rates for people who are already taking Tecfidera (dimethyl fumerate) but have active relapsing MS.
The trial will involve 600 people with active relapsing MS and is due to finish in 2020.
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?
Although detailed data is not yet available, the most frequent side effects reported for ponesimod were shortness of breath and asymptomatic liver enzyme elevations.
How does ponesimod compare with current therapies?
Ponesimod is being compared to teriflunomide in a phase 3 trial.
When is ponesimod likely to become available?
The results of the phase 3 ponesimod trial are expected in 2019. If these results are positive Actelion will be able to submit a application to the European Medicines Agency, and the licensing process can begin.