Favorable Risk-Benefit Profile for Ozanimod in Relapsing Multiple Sclerosis
VANCOUVER, BC—Ozanimod (RPC1063), an oral selective S1P receptor modulator currently in development, has shown efficacy in reducing relapse rates in relapsing multiple sclerosis when compared with placebo. The promising results were demonstrated in a blinded extension trial presented at the 68th AAN Annual Meeting.
"Ozanimod had demonstrated efficacy in low and high doses in the 24-week RADIANCE Phase 2/3 trial," said lead author Krzysztof Selmaj, MD, Medical University of Lodz, Lodz, Poland. "We extended the trial for a further 48-weeks to test the long term efficacy and safety."
Low dosage (LD) was defined as being 0.5mg and high dosage (HD) was 1mg. The 85 LD and 81 HD participants from the first trial continued with the same ozanimod dosage level for the extension, while the placebo patients were re-randomized (LD=41 and HD=42).
A total of 230 (92% of those who initiated) completed the extension trial. "Unadjusted annualized relapse rates declined from 0.43 for the LDc group and 0.26 for the HDc group at Week 24, to 0.26 and 0.15 at Week 72 for both groups, respectively," reported Dr Selmaj. The mean±SD GdE-lesions in LDc and HDc groups at Week 72 were 0.4±1.4 and 0.2±0.6; this was similar to the figures at Week 24. The proportion of GdE-lesion-free patients was also comparable to the percentages displayed at Week 24: 73% and 88%.
Between Weeks 24 and 72, no enlarging or new T2-lesions, or increase in expanded disability status scale, or relapses were noted in 44% of patients. Overall, study authors reported that NEDA rose from 42% to 57% from Weeks 24 to 72. No notable cardiac, pulmonary, ophthalmologic or malignancy adverse events were observed. The most common adverse events were minor infections and headaches.
No notable cardiac, pulmonary, ophthalmologic or malignancy adverse events were observed. One patient transiently had a minimum hourly heart rate <45bpm. The most common adverse events were minor infections and headaches.
"Both doses of ozanimod showed efficacy over 72 weeks on MRI and clinical measures of MS disease activity in patients continuing ozanimod and those switching from placebo at Week 24," concluded Dr. Selmaj. Findings from the Phase 2 RADIANCE core study and the extension phase support a favorable risk-benefit profile for ozanimod that further supports the international Phase 3 RADIANCE and SUNBEAM trials.