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) β-1a (Avonex, from Biogen [Nasdaq: BIIB]).
Ozanimod is being developed by blood cancers specialist Celgene (Nasdaq; CELG) and, if approved, it would be the company’s first foray into the highly competitive multiple sclerosis market. The US biotech major gained rights to ozanimod through its acquisition of Receptos for $7.2 billion in 2015. The drug is being developed in other indications, including ulcerative colitis and inflammatory bowel disease. Celgene’s shares edged up 1.6% to $120.56 by late morning trading.
Regulatory filing expected by year-end
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