Relapsing multiple sclerosis: oral Ozanimod has shown improvements compared to Interferon beta-1a for the primary endpoint of annualized relapse rate
SUNBEAM trial, evaluating the efficacy and safety of O)zanimod, an investigational oral, selective S1P 1 and 5 receptor modulator, in patients with relapsing multiple sclerosis ( RMS ), met the primary endpoint in reducing annualized relapse rate ( ARR ), compared to weekly Interferon ( IFN ) beta-1a ( Avonex ).
SUNBEAM evaluated two orally administered treatment doses ( 0.5 mg and 1 mg ) of Ozanimod, with patients treated for at least one year.
The randomized phase III trial enrolled 1,346 RMS patients in 20 countries.
Top-line data have shown that both the Ozanimod 1 mg and 0.5 mg treatment arms demonstrated statistically significant and clinically meaningful improvements compared to Interferon beta-1a for the primary endpoint of annualized relapse rate and the measured secondary endpoints of the number of Gadolinium-enhancing MRI lesions and the number of new or enlarging T2 MRI lesions at month 12.
The overall safety and tolerability profile was consistent with results from previously reported phase II RMS ( RADIANCE ) and phase II ulcerative colitis ( TOUCHSTONE ) trials.
Ozanimod is a novel, oral, selective, sphingosine 1-phosphate 1 ( S1PR1 ) and 5 ( S1PR5 ) receptor modulator in development for immune-inflammatory indications including relapsing multiple sclerosis, ulcerative colitis and Crohn’s disease.
Selective binding with S1PR1 receptors is believed to inhibit a specific sub set of activated lymphocytes from migrating to sites of inflammation.
The result is a reduction of circulating T and B lymphocytes that leads to anti-inflammatory activity. Importantly, immune surveillance is maintained.
Selective binding with S1PR5 receptors is believed to activate specific cells within the CNS. This has the potential to enhance remyelination and prevent synaptic defects. Ultimately, neurological damage may be prevented.
Multiple sclerosis is a disease in which the immune system attacks the protective myelin sheath that covers the nerves. The myelin damage disrupts communication between the brain and the rest of the body. Ultimately, the nerves themselves may deteriorate, a process that's currently irreversible.
Signs and symptoms vary widely, depending on the amount of damage and the nerves affected.
Some people with severe multiple sclerosis may lose the ability to walk independently, while others experience long periods of remission during which they develop no new symptoms.
Multiple sclerosis affects approximately 400,000 people in the U.S. and approximately 2.5 million people worldwide.
RMS is characterized by clearly defined attacks of worsening neurologic function. These attacks, often called relapses, flare-ups or exacerbations, are followed by partial or complete recovery periods ( remissions ), during which symptoms improve partially or completely, and there is no apparent progression of disease. RMS is the most common disease course at the time of diagnosis.
Approximately 85% of people are initially diagnosed with relapsing multiple sclerosis, compared with 10-15% with progressive forms of the disease. ( Xagena )
Source: Celgene, 2017