ZEPOSIA Delivered Powerful Efficacy in Reducing ARR vs Avonex in Pivotal Trials1

In the ongoing open-label extension study, patients continuously treated with ZEPOSIA up to 5 yearsa had an ARR of 0.0952
Chart comparing ARR in pivotal trials and OLE between SUNBEAM and RADIANCE trials Chart comparing ARR in pivotal trials and OLE between SUNBEAM and RADIANCE trials
A relapse was defined as the occurrence of new or worsening neurological symptoms persisting for more than 24 hours attributable to MS and immediately preceded by a relatively stable or improving neurological state of at least 30 days.4,5
*DAYBREAK is an ongoing OLE trial that enrolled participants from multiple randomized Phase 1, 2, or 3 studies, including SUNBEAM and RADIANCE, and is presented as an interim analysis with a data cutoff of February 2, 2021. Endpoints were analyzed descriptively.2,3
aAt data cutoff, mean (range) continuous ZEPOSIA 0.92 mg exposure in DAYBREAK was 47.6 (0.43-62.7) months.6
bStudy period includes DAYBREAK Day 1 through last treatment date or the data cutoff date of December 20, 2019.2,3
cAt data cutoff date of February 2, 2021.2
Proven Superior vs Avonex in Reducing Lesions Across All Secondary Measures of MRI Activity1
Chart comparing reduction of GdE lesions and new/enlarging T2 lesions between SUNBEAM and RADIANCE trials Chart comparing reduction of GdE lesions and new/enlarging T2 lesions between SUNBEAM and RADIANCE trials
In the 1-year SUNBEAM study, brain MRIs were performed at baseline, Month 6, and Month 12.
In the 2-year RADIANCE study, brain MRIs were performed at baseline, Month 12, and Month 24.4,5
9 of 10 Patients Showed No Confirmed 3-Month
Disability Progression1
Secondary endpoint, confirmed disability progression at 2 years Secondary endpoint, confirmed disability progression at 2 years

92.4%

vs 92.2% For Avonex Showed No Confirmed
3-Month Disability Progression

POOLED ANALYSIS

92.4% vs 92.2%

For Avonex Showed No Confirmed
3-Month Disability Progression

Graphic depicting the 3-month disability progression rate in patients
Statistical significance was not reached for the pooled CDP.
7.6% of patients treated with ZEPOSIA (n=67/880) experienced 3-month confirmed disability progression (CDP), as measured by EDSS, similar to Avonex (7.8%; n=69/889) (P=NS)1,5
CDP was defined as at least a 1-point increase from baseline EDSS confirmed after 3 months and after 6 months. CDP was prospectively evaluated in a pooled analysis from the SUNBEAM and RADIANCE studies.
EDSS=Expanded Disability Status Score; NS=nonsignificant.
Compelling Efficacy
in Brain Volume Loss Data
in Pivotal Trials4,5
SECONDARY ENDPOINT WHOLE BRAIN VOLUME LOSS
Mean percent change from baseline
SUNBEAM (1 YEAR)
31%
RELATIVE REDUCTION
ZEPOSIA: –0.41 (n=397)
vs Avonex: –0.61 (n=406)
 
 
RADIANCE (2 YEARS)
26%
RELATIVE REDUCTION
ZEPOSIA: –0.71 (n=390)
vs Avonex: –0.94 (n=397)
Volume loss endpoints were not part of the statistical analysis hierarchy.
In the 1-year SUNBEAM study, brain MRIs were performed at baseline, Month 6, and Month 12.4
In the 2-year RADIANCE study, brain MRIs were performed at baseline, Month 12, and Month 24.5
EXPLORATORY ENDPOINT THALAMIC VOLUME LOSS
Mean percent change from baseline
SUNBEAM (1 YEAR)
32%
RELATIVE REDUCTION
ZEPOSIA: –1.12 (n=393)
vs Avonex: –1.72 (n=406)
 
 
RADIANCE (2 YEARS)
27%
RELATIVE REDUCTION
ZEPOSIA: –1.40 (n=385)
vs Avonex: –1.85 (n=391)
Volume loss endpoints were not part of the statistical analysis hierarchy.
In the 1-year SUNBEAM study, brain MRIs were performed at baseline, Month 6, and Month 12.4
In the 2-year RADIANCE study, brain MRIs were performed at baseline, Month 12, and Month 24.5
EXPLORATORY ENDPOINT CORTICAL GREY MATTER VOLUME LOSS
Chart comparing cortical grey matter volume loss between SUNBEAM and RADIANCE trials Chart comparing cortical grey matter volume loss between SUNBEAM and RADIANCE trials
Volume loss endpoints were not part of the statistical analysis hierarchy.
In the 1-year SUNBEAM study, brain MRIs were performed at baseline, Month 6, and Month 12.4
In the 2-year RADIANCE study, brain MRIs were performed at baseline, Month 12, and Month 24.5
Post Hoc Analysis: SDMT—Cognitive Processing Speed Data (SUNBEAM and OLE)7,8
Chart depicting percentage of patients with improved, stable, or worsened SDMT scores at 1 year and  relative to SUNBEAM trial baseline at 42 months Chart depicting percentage of patients with improved, stable, or worsened SDMT scores at 1 year Chart depicting percentage of patients with improved, stable, or worsened SDMT scores at 1 year
This endpoint was not part of the statistical analysis hierarchy for SUNBEAM and was analyzed descriptively in DAYBREAK.
The MSFC was a secondary endpoint made up of 3 components: 9-hole peg test (arm/hand function), timed 25-foot walk (ambulation), and SDMT (cognitive function).4,7,9
SDMT is a tool that measures cognitive processing speed.10
aData cutoff for this interim analysis was December 20, 2019.
MSFC=Multiple Sclerosis Functional Composite.
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