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Ponesimod

Other names: ACT-128800

Ponesimod is a new drug treatment under investigation for relapsing remitting multiple sclerosis (MS). It is taken as a tablet once daily.

Summary

Ponesimod for relapsing remitting MS: Phase III

Ponesimod is a new drug treatment under investigation for relapsing remitting multiple sclerosis (MS). It is taken as a tablet once daily.

  • Ponesimod causes lymphocytes to be retained in lymph glands
  • In phase II relapsing remitting MS studies, ponesimod reduced the number of new active lesions by up to 77% compared to placebo
  • In a phase II study, the most common side effects were anxiety, dizziness, breathlessness, raised liver enzymes, influenza, sleeplessness and peripheral oedema (swelling of lower legs)

How does ponesimod work?

Ponesimod belongs to the same class of drugs as Gilenya (fingolimod). It acts on certain types of white blood cells (lymphocytes) which are involved in the autoimmune attack on myelin seen in MS. It binds to special locations (or receptors) on the surface of the lymphocytes, called sphingosine-1-phosphate receptors (S1P-R). This causes a larger proportion of lymphocytes to be retained in the lymph glands. The number of activated lymphocytes reaching the brain is decreased, resulting in reduced immune attack on nerve cells in the brain and spinal cord.

How is ponesimod taken?

Ponesimod is taken as a tablet, once daily.

Ponesimod research

What are the results so far?

In a phase II study, 464 people with relapsing remitting MS took one of three doses of ponesimod or placebo for 24 weeks.  The main measure was the number of new active lesions seen on MRI.  Daily doses of 10, 20 and 40 mg ponesimod reduced the number of lesions by 43%, 83% and 77% compared to placebo.  The highest dose of ponesimod reduced relapses by 52% compared to placebo.

What further research is planned?

  • OPTIMUM - ponesimod compared to Aubagio (teriflunomide)

This phase III study has recruited 1100 participants with relapsing MS who are taking either ponesimod or Aubagio daily for 2 years.  The main aim of the study is to assess whether ponesimod is better than Aubagio at reducing relapse rate.  The study will also measure disability progression, effect on brain volume, time to first relapse, number of new active lesions and fatigue.
Estimated completion date April 2019.
Further details of this study.

  • POINT - ponesimod combined with Tecfidera (dimethyl fumarate)

This phase III study is recruiting 600 participants with active relapsing MS who will take either ponesimod or placebo in addition to Tecfidera for at least 60 weeks.  The main aim of the study is to assess whether the combination of ponesimod and Tecfidera is more effective than Tecfidera alone at reducing the number of relapses. The study will also measure disability progression, effect on brain volume, time to first relapse, disease activity observed on MRI scans, fatigue, and adverse events.
Estimated completion date March 2020.
Further details of this study.

Side effects

The most common side effects reported in the phase II study were anxiety, dizziness, breathlessness, raised liver enzymes, influenza, sleeplessness and peripheral oedema (swelling of lower legs). 

Like Gilenya, ponesimod causes an initial temporary slowing of heart rate. This has been minimised in clinical trials by starting people on low doses of ponesimod and gradually increasing over several days.

More references

  • Olsson T, et al. Oral ponesimod in relapsing-remitting multiple sclerosis: a randomised phase II trial. J Neurol Neurosurg Psychiatry. 2014 85(11):1198-208. Read the full paper

Last reviewed: November 2017
This page will be reviewed within three years

More references

  • Olsson T, et al. Oral ponesimod in relapsing-remitting multiple sclerosis: a randomised phase II trial. J Neurol Neurosurg Psychiatry. 2014 85(11):1198-208. Read the full paper

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