Oral Ozanimod, compared to Interferon beta-1a, reduces annualized relapse rate in patients with relapsing multiple sclerosis
The phase III SUNBEAM trial, evaluating the efficacy and safety of Ozanimod, 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.
Data have shown that both the Ozanimod 1 mg and 0.5 mg treatment arms demonstrated statistically significant and clinically meaningful improvements compared to Avonex for the primary endpoint of ARR 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 subset 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. ( Xagena )
Source: Celgene, 2017