Phase III trial of oral ozanimod in patients with relapsing MS meets endpoints

US biotech firm Celgene (Nasdaq: CELG) saw its shares dip 2.8% to $115.71 in morning trading on Monday, despite reporting positive new clinical data for its multiple sclerosis drug candidate ozanimod.

The Phase III RADIANCE trial, a second pivotal study, 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, from Biogen).

RADIANCE evaluated two doses (0.5mg and 1mg) of oral ozanimod, with patients treated for two years. The trial enrolled 1,313 RMS patients in 21 countries. Both doses demonstrated statistically-significant and clinically-meaningful reductions in the primary endpoint of ARR and the key secondary endpoints of the number of new or enlarging T2 MRI lesions over 24 months of treatment compared to Avonex and the number of gadolinium-enhancing MRI lesions at 24 months of treatment compared to Avonex.