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Nearly 10 Yearsa of Patient Experience From Phase 1 Trials Through Ongoing Open-Label Extension Study1-5

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The Largest Number of Patients With RMS Studied in Pivotal
Head-to-Head Trials With an Active Comparator (N=2659)2,3b
SUNBEAM and RADIANCE study designs SUNBEAM and RADIANCE study designs
PHASE 3 ENDPOINTS1
PRIMARY
  • Annualized Relapse Rate
KEY SECONDARY
  • GdE Lesions
  • New/Enlarging T2 Lesions
  • Confirmed Disability Progression
aFrom 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 oral once daily ZEPOSIA 0.92 mg in the parent trials and DAYBREAK was 70.4 months.1,4
b2659 patients includes all 3 arms of the study: the 0.92-mg oral daily dose of ZEPOSIA, the 0.46-mg oral daily dose of ZEPOSIA, and the 30-μg weekly injection of Avonex.1-3
Chart outlining DAYBREAK study structure Chart outlining DAYBREAK study structure
DAYBREAK ENDPOINTS6
PRIMARY
  • Long-Term Safety
KEY SECONDARY
  • Annualized Relapse Rate
  • GdE Lesions
  • New/Enlarging T2 Lesions
cDAYBREAK 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 orally once daily population (n=881) and additional participants who received any study treatment other than once daily oral 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).1,4,5
dAt data cutoff, mean (range) continuous once daily oral ozanimod 0.92 mg exposure in DAYBREAK was 56.4 (0.03-74.7) months.1,4
eThe overall population contains all patients who received at least 1 dose of once daily oral ZEPOSIA 0.92 mg during DAYBREAK OLE. The continuous population includes patients who received once daily oral ZEPOSIA 0.92 mg in randomized phase 1-3 studies and continued on ZEPOSIA in DAYBREAK. The recommended maintenance dosage is 0.92 mg orally once daily. The recommended maintenance dosage in patients with mild or moderate chronic hepatic impairment (Child-Pugh class A or B) is 0.92 mg once every other day.1,4,5
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 Characteristics1f
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 therapiesg 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
fIncludes the once daily oral 0.92 mg dose of ZEPOSIA and the 30-μg dose of Avonex. The 0.46-mg dose of ZEPOSIA is not included.1
gIncludes 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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