Ozanimod (formerly RPC1063) is an investigational, oral, selective sphingosine 1-phosphate (S1P) receptor modulator currently in development for people with relapsing-remitting multiple sclerosis (RRMS) or inflammatory bowel disease.
S1P receptor modulators interfere with S1P signaling. They block lymphocytes (immune cells) from receiving exit signals inside the lymph nodes, which keeps the immune cells trapped inside the node. The result is a reduction of circulating T- and B-cells leading to anti-inflammatory activity because it stops the migration of certain immune cells to the actual sites of inflammation.
Studies Involving Ozanimod
In early September, Ozanimod developer Celgene announced positive results from its Phase 2 RADIANCE study (NCT01628393). The study demonstrated that ozanimod was effective because it reduced total brain lesions, as determined by MRI scans. The results of the 2-year safety and effectiveness study further emphasized the potential of ozanimod to provide a new oral therapeutic option for people with RRMS.
Study participants experienced three serious adverse effects — optic neuritis, unexplained pain, and cellular changes to the cervix — but the effects were not proven to be related to the therapy. Other reactions included headaches, urinary tract infections, and an initial heart rate increase.
The Phase 3 portion of the RADIANCE study began in 2013 by Receptos (now owned by Celgene) under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). The ongoing Phase 3 portion (NCT02047734) compares 0.5 mg and 1.0 mg of ozanimod against interferon beta-1a (Avonex) in approximately 1,200 RRMS patients.
Another ongoing Phase 3 trial is SUNBEAM (NCT02294058). The randomized, double-blind study is also comparing 0.5 mg and 1.0 mg of oral ozanimod against interferon beta-1a (Avonex) in 1,200 people with RRMS.
If the Phase 3 trials are successful, Celgene will present its data to the FDA and European Medicines Agency (EMA) to begin drug licensing processes.
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