The phase 3 SUNBEAM trial, which evaluated the efficacy and safety of ozanimod (Celgene), an investigational oral, selective sphingosine phosphate receptor 1 (S1P1) and S1P5 modulator, in patients with relapsing multiple sclerosis (RMS), met its primary endpoint in reducing the annualized relapse rate (ARR) compared with weekly interferon (IFN) beta-1a (Avonex, Biogen).
The trial evaluated two orally administered treatment doses (0.5 mg and 1 mg) of ozanimod, with patients treated for at least one year. The multicenter, randomized, double-blind, double-dummy, active-controlled phase 3 trial enrolled 1,346 RMS patients in 20 countries.
Top-line data showed that both the ozanimod 1-mg and 0.5-mg treatment arms demonstrated statistically significant and clinically meaningful improvements compared with Avonex for the primary endpoint of ARR and the measured secondary endpoints of the number of gadolinium-enhancing magnetic resonance imaging (MRI) lesions and the number of new or enlarging T2 MRI lesions at month 12. As agreed to in the Special Protocol Assessment with the FDA, a prespecified analysis on the time to onset of disability progression will be conducted using pooled results from both the SUNBEAM and RADIANCE phase 3 trials.
Ozanimod is in development for immune-inflammatory indications including RMS, ulcerative colitis, and Crohn’s disease. Selective binding with S1P1 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 S1P5 receptors is believed to activate specific cells within the central nervous system. This has the potential to enhance remyelination and prevent synaptic defects. Ultimately, neurological damage may be prevented.
Ozanimod is an investigational compound that is not approved for any use in any country.
Source: Celgene; February 17, 2017.