Up to 8 Years* of Patient Exposure From Phase 1 Trials Through Ongoing Open-Label Extension Study1-4

The Largest Number of Patients With RMS Studied in Pivotal
Head-to-Head Trials With an Active Comparator (N=2659)2,3a
SUNBEAM and RADIANCE study designs SUNBEAM and RADIANCE study designs
PIVOTAL STUDY ENDPOINTS1
PRIMARY
  • Annualized Relapse Rate
KEY SECONDARY
  • GdE Lesions
  • New/Enlarging T2 Lesions
  • Confirmed Disability Progression
Chart outlining DAYBREAK study structure Chart outlining DAYBREAK study structure
OPEN-LABEL STUDY ENDPOINTS4,5
PRIMARY
  • Long-Term Safety
KEY SECONDARY
  • Annualized Relapse Rate
  • GdE Lesions
  • New/Enlarging T2 Lesions

The patient population evaluated in this analysis included those who received ZEPOSIA 0.92 mg (n=881) and completed the randomized Phase 1, 2, or 3 trials.4 Endpoints were analyzed descriptively in the DAYBREAK study5

a2659 patients include all 3 arms of the study: the 0.92 mg dose of ZEPOSIA, the 0.46-mg dose of ZEPOSIA (not approved for maintenance dose), and the 30-μg dose of Avonex.2,3
bDAYBREAK is an ongoing open-label extension (OLE) trial that enrolled participants from multiple randomized phase 1 to 3 studies, including SUNBEAM and RADIANCE, and is presented as an interim analysis with a data cutoff of February 2, 2021.
cAt data cutoff, mean (range) continuous ozanimod 0.92 mg exposure in DAYBREAK was 47.6 (0.43-62.7) months.6
*From first patient randomized (October 18, 2012) through the DAYBREAK data cutoff (February 2, 2021), mean (range) continuous ozanimod 0.92 mg exposure was 67.4 (6.01-98.8) months.7
RMS=relapsing multiple sclerosis.
Key Inclusion Criteria1-3
  • Ages 18 to 55
  • EDSS score of 0.0 to 5.0
  • Experienced ≥1 relapse within the previous year
    OR 1 relapse within prior 2 years with ≥1 GdEbr
    lesion in prior year
Key Exclusion Criteria1-3
  • Primary progressive MS
  • Specific cardiac conditions (eg, recent MI/stroke,
    prolonged QTcF interval)
  • Resting heart rate <55 bpm at screening
  • T1DM or uncontrolled T2DM with hemoglobin A1C >9%
    (SUNBEAM) OR >7% (RADIANCE), or patients with
    diabetes with significant comorbidities
Baseline Characteristicsd
Characteristics (Mean Or %) SUNBEAM RADIANCE
Age (years) 35.4 35.6
Race, white 99.8% 98%
Sex, female 65% 68%
Time since MS symptom onset (years) 6.9 6.6
EDSS score (median) 2.5 2.5
Previously treated with MS therapiese 31% 29%
Number of relapses in prior year 1.3 1.3
≥1 T1 GdE lesion 48% 43%
Number of T1 GdE lesions 1.8 1.7
dIncludes 0.92 mg dose of ZEPOSIA and the 30-g dose of Avonex. The 0.46-mg maintenance dose of ZEPOSIA (not approved for maintenance dose) is not included.1
eIncludes those previously treated with non-steroid therapy for MS.1
A1C=glycated hemoglobin; BPM=beats per minute; EDSS=Expanded Disability Status Scale; MI=myocardial infarction; MS=multiple sclerosis; QTcF=prolonged Fridericia-corrected QT; T1DM=type 1 diabetes mellitus; T2DM=type 2 diabetes mellitus.
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