The findings from the two pivotal phase 3 (SUNBEAM and RADIANCE Part B) trials pave the way for ozanimod to enter the New Drug Approval process with the U.S. Food and Drug Administration (FDA).
Ozanimod was developed by scientists at The Scripps Research Institute (TSRI), it is a novel, oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator, and was compared to the first-line treatment, Avonex (interferon beta-1a) (IFN), in patients with relapsing multiple sclerosis (RMS).
RMS is the most common type of multiple sclerosis. Treating inflammation in RMS patients is key to reducing their disease relapses. The drug blocks sources of inflammation in RMS by acting as a sphingosine 1-phosphate 1 (S1PR1) receptor agonist.
The RADIANCE Part B study evaluated two doses (1 mg and 0.5 mg) of oral ozanimod compared with IFN in 1,320 patients with RMS in 21 countries treated for two years. The SUNBEAM study evaluated two doses (1 mg and 0.5 mg) of oral ozanimod in 1,346 patients with RMS in 20 countries treated for at least one year.
The treatment demonstrated a significant reduction in new or enlarging T2 lesions over one year to 1 mg (48 percent, p < 0.0001) and 0.5 mg (25 percent, p=0.0032) compared with IFN. A significant reduction in gadolinium-enhanced MRI lesions at 1 year was also demonstrated for ozanimod 1 mg (63 percent, p < 0.0001) and ozanimod 0.5 mg (34 percent, p=0.0182) compared with IFN. Ozanimod significantly slowed the loss of brain volume compared with IFN–a hallmark of the disease that causes brain atrophy, disease progression and cognitive impairment.