An article about ozanimod from the MSAA Research News, April 28, 2016:
Trial Results Presented for Oral Ozanimod
[In] February, the 72-week Phase II results were presented from the RADIANCE trial, which studied the effectiveness of ozanimod treatment in individuals with relapsing-remitting MS (RRMS). Previously known as RPC1063, this investigational medication is now under development by Celgene Corporation.
Ozanimod is a selective S1P 1 and 5 receptor modulator. It was given as a once-daily pill in the Phase II RADIANCE trial and was compared at two different doses (0.5 mg and 1 mg) with placebo. A total of 258 RRMS patients were studied in this double-blind trial, which ran for 24 weeks and was then followed by a 48-week blinded-extension period. After the initial 24 weeks, individuals taking the placebo were randomized to either dose of the medication.
At the conclusion of the 72-week study, patients in groups taking either dose of ozanimod showed a significant decrease in the mean number of gadolinium-enhanced (GdE) lesions. A significant number of participants were also free of GdE lesions, and relapse rates were reduced as well.
The most common side effects reported were minor infections, back pain, and headache. Elevated liver enzymes were seen in 3 to 4 percent of the participants. No serious cardiac events were reported.
Ozanimod is now being studied in two Phase III trials, SUNBEAM and a two-year portion of RADIANCE.