MedicalResearch.com Interview with:
Dr Jeffrey A Cohen MD
Mellen Center, Neurological Institute
Cleveland Clinic, Cleveland
OH 44195, USA
Medical Research: What is the background for this study? What are the main findings?
Dr. Cohen: Fingolimod, a non-selective sphingosine 1-phosphate receptor (S1PR) modulator, was the first oral medication approved to treat relapsing multiple sclerosis. Though generally well tolerated, fingolimod’s first dose cardiac effects and other potential adverse effects complicate its use. Ozanimod is a selective S1PR modulator with several other potentially advantageous pharmacologic properties.
The results of phase 2 RADIANCE trial were recently published. In this trial, participants were randomized to placebo (n=88), ozanimod 0.5 mg (n=87), or ozanimod 1 mg (n=83) PO once daily for 24 weeks. The mean cumulative number of gadolinium-enhancing lesions on monthly MRI scans at weeks 12-24, the primary endpoint, was reduced from 11.1 +/- 29.9 with placebo to 1.5 +/- 3.7 with ozanimod 0.5 mg and 1.5 +/- 3.4 with ozanimod 1 mg (both p<0.0001). Other MRI endpoints supported the primary endpoint. Ozanimod was well tolerated with good safety. Importantly, the dose up-titration protocol effectively mitigated first dose cardiac effects.
Medical Research: What should clinicians and patients take away from your report?
Dr. Cohen: The phase 2 RADIANCE study demonstrated efficacy of both doses of ozanimod compared to placebo with favorable safety and tolerability.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Cohen: These results justify proceeding with the RADIANCE and SUNBEAM phase 3 studies, which are ongoing. These studies are intended to confirm and extend the results of the RADIANCE phase 2 study.
Safety and efficacy of the selective sphingosine 1-phosphate receptor modulator ozanimod in relapsing multiple sclerosis (RADIANCE): a randomised, placebo-controlled, phase 2 trial
Cohen, Jeffrey A et al.
The Lancet Neurology , Volume 0 , Issue 0 ,
Dr. Jeffrey Cohen (2016). New Immune Modulator Ozanimod Shows Promise in Multiple Sclerosis