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Up to 9 Years* of Patient Exposure From Phase 1 Trials Through Ongoing Open-Label Extension Study1-5

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
  • Annualized Relapse Rate
  • GdE Lesions
  • New/Enlarging T2 Lesions
  • Confirmed Disability Progression
*From the first patient randomized (October 18, 2012) through the DAYBREAK data cutoff (February 1, 2022), the maximum continuous exposure was 110.8 months. The mean exposure to ZEPOSIA 0.92 mg in the parent trials and DAYBREAK was 70.4 months.4
a2659 patients includes all 3 arms of the study: the 0.92-mg dose of ZEPOSIA, the 0.46-mg dose of ZEPOSIA, and the 30-μg dose of Avonex.2,3
Chart outlining DAYBREAK study structure Chart outlining DAYBREAK study structure
  • Long-Term Safety
  • Annualized Relapse Rate
  • GdE Lesions
  • New/Enlarging T2 Lesions
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 1, 2022. Endpoints were analyzed descriptively. The overall population (n=2494) in DAYBREAK consists of the continuous 0.92 mg population (n=881) and additional participants who received any study treatment other than ZEPOSIA 0.92 mg during the parent studies, including 10 participants from phase 1 (ZEPOSIA 0.46 mg, n=10), 109 participants from phase 2 (ZEPOSIA 0.46 mg, n=109), 805 participants from phase 3 SUNBEAM (Avonex 30 μg, n=392; ZEPOSIA 0.46 mg, n=413), and 689 participants from phase 3 RADIANCE (Avonex 30 μg, n=344; ZEPOSIA 0.46 mg, n=345).4,5
cAt data cutoff, mean (range) continuous ozanimod 0.92 mg exposure in DAYBREAK was 56.4 (0.03-74.7) months.4
dThe overall population contains all patients who received at least 1 dose of ZEPOSIA 0.92 mg during DAYBREAK OLE. The continuous population includes patients who received ZEPOSIA 0.92 mg in randomized phase 1-3 studies and continued on ZEPOSIA in DAYBREAK. The recommended dose for ZEPOSIA is 0.92 mg.1,4
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 GdE
    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 Characteristics1d
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 the 0.92-mg dose of ZEPOSIA and the 30-μg dose of Avonex. The 0.46-mg dose of ZEPOSIA 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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