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First Results Announced from Second Phase III Trial of Oral Ozanimod in People with Relapsing MS

May 23, 2017

SUMMARY
•   First results were announced from a second phase III study in 1,313 people with relapsing MS. Oral ozanimod (Celgene Corporation) significantly reduced relapse rates compared with Avonex® (interferon beta-1a, Biogen) over two years, and also reduced MRI-detected disease activity and brain atrophy.
•   The results of the RADIANCE trial were announced in a May 22, 2017 press release from Celgene Corporation. The company reported on results from a first phase III trial (the SUNBEAM study) in February.
  • In a pooled analysis of both phase III studies, ozanimod was not shown to slow disability progression significantly more than Avonex.
  • According to the press release, the company will present detailed results from both studies at an upcoming medical meeting, and plans to submit a New Drug Application to the U.S. Food and Drug Administration by the end of 2017.
DETAILS
Background: Ozanimod is a selective sphingosine 1-phosphate receptor modulator. It is thought to act by retaining certain white blood cells in the body’s lymph nodes, keeping them out of circulation and from entering the central nervous system. In an earlier phase II trial, in 258 participants with relapsing MS, disease activity on MRI scans was reduced in people taking two different doses of ozanimod, compared to people taking placebo. (Lancet Neurology, 2016 Apr;15(4):373-81) The company reported on results from a first phase III trial (the SUNBEAM study) in February.
 
The Study: For the second phase III trial, all 1,313 participants were randomly assigned to one of three treatment groups, taking either daily oral ozanimod (.5 mg) and an inactive placebo injected into muscle once weekly; daily oral ozanimod (1 mg) and inactive placebo injected into muscle once weekly; or Avonex and an oral placebo daily for 24 months.
 
The study met the primary endpoint in reducing the relapse rate over two years, as well as the secondary MRI measures of disease activity. In a pooled analysis of both phase III studies, ozanimod was not shown to slow disability progression significantly more than Avonex. A very low rate of disability progression was observed in all three treatment groups. There were significant reductions in the loss of brain tissue volume with ozanimod treatment in both studies compared with Avonex.
 
According to the press release, the overall safety and tolerability profile was similar to the other phase III and phase II study, but no further information was provided. The most common adverse events reported from the phase II study were respiratory infections, headache, and urinary tract infections.
 
Next Steps: The results of the RADIANCE trial were announced in a May 22, 2017 press release from Celgene Corporation. According to the press release, the company will present detailed results from both studies at an upcoming medical meeting, and plans to submit a New Drug Application to the U.S. Food and Drug Administration by the end of 2017.
 
Avonex is a registered trademark of Biogen, Inc.

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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