Other names: RPC-1063
Ozanimod is a new drug treatment under investigation for relapsing remitting multiple sclerosis (MS). It is taken as a tablet once daily.
Ozanimod for relapsing remitting MS: Licensing
- Ozanimod causes lymphocytes to be retained in lymph glands
- In relapsing remitting MS, ozanimod reduced relapse rates by approximately 38% compared to beta interferon
- In phase III studies, the most common side effects were colds, headache, chest infections and urinary tract infections
How does ozanimod work?
Ozanimod 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 ozanimod taken?
Ozanimod is taken as a tablet, once daily.
What are the results so far?
In a phase II study, 258 people with relapsing remitting MS took one of two doses of ozanimod or placebo for 24 weeks. The main measure was the number of new active lesions seen on MRI. Ozanimod significantly reduced the number of lesions compared to placebo.
- SUNBEAM - ozanimod compared to interferon beta 1a (Avonex)
1346 people with relapsing MS were recruited to this phase III study. Participants took one of two doses of ozanimod or interferon beta 1a (Avonex) for one year. For the group taking 0.5mg ozanimod, the annual relapse rate was 0.24, a 31% reduction compared to Avonex. For the group taking 1.0mg ozanimod, the relapse rate was 0.18, representing a 48% reduction compared to Avonex.
Compared to Avonex, both doses of ozanimod also significantly reduced the number of new active lesions seen on MRI. Changes in brain volume were not significantly different between the two doses of ozanimod and Avonex.
- RADIANCE - ozanimod compared to interferon beta 1a (Avonex)
This phase III study recruited 1320 participants with relapsing MS who took one of two doses of ozanimod or interferon beta 1a (Avonex) for two years. The main aim of the study was to compare relapse rates for ozanimod and Avonex. For the group taking 0.5mg ozanimod, the annual relapse rate was 0.22, a 21% reduction compared to Avonex. For the group taking 1.0mg ozanimod, the relapse rate was 0.17, a 38% reduction compared to Avonex. Compared to Avonex, both doses of ozanimod also significantly reduced the number of new active lesions seen on MRI. Both doses also reduced brain volume loss compared to Avonex.
The most common side effects reported in the phase III studies were nasopharyngitis (common cold), headache, chest infections and urinary tract infections. Ozanimod caused caused temporary increases in liver enzymes which generally returned to normal levels without the need to stop treatment.
Unlike Gilenya, ozanimod did not cause an initial temporary slowing of heart rate.
- Lancet Neurol. 2016;15(4):373-81. Abstract Safety and efficacy of the selective sphingosine 1-phosphate receptor modulator ozanimod in relapsing multiple sclerosis (RADIANCE): a randomised, placebo-controlled, phase 2 trial.
- Mult Scler 2018 Jul 25; 1352458518789884 [Epub ahead of print] Full article Efficacy and safety of ozanimod in multiple sclerosis: Dose-blinded extension of a randomized phase II study
- Efficacy and Safety Results from First Phase III Trial of Oral Ozanimod (SUNBEAM) Versus an Active Comparator in Relapsing Multiple Sclerosis Presented at MSParis2017 Company press release
- Efficacy and Safety Results from Second Phase III Trial (RADIANCE™ Part B) of Oral Ozanimod Versus an Active Comparator in Relapsing Multiple Sclerosis Presented at MSParis2017 Company press release
Drugs in development
New MS medications can take years in development until they reach us. Find out about new drugs on the horizon for MS.
Drug development process
Find out about the different stages involved in making a new medicine.