Half-Year 2022 Financial and Clinical Trials Update
Enspryng (satralizumab, RG6168, SA237)
Anti-IL-6 receptor humanized monoclonal antibody
Indication
Neuromyelitis optica spectrum disorder (NMOSD)
Phase/study
# of patients
Design
Primary endpoint
Enspryng monotherapy:
Phase III
SAkuraStar
N=95
.
• ARM A: Enspryng 120mg SC monthly
• ARM B: Placebo SC monthly
•Efficacy (time to first relapse), safety and PK/PD
Primary endpoint met Q4 2018
"
Data presented at ECTRIMS 2019
■ Published in Lancet Neurology 2020; 19(5): 402-412
Status
CT Identifier
NCT02073279
Phase III
SAkuraSky
N=83
Add-on therapy of Enspryng:
•
ARM A: Enspryng 120mg SC monthly
Roche
• ARM B: Placebo SC monthly
Both arms on top of baseline therapies: azathioprine, mycophenolate mofetil
or oral corticosteroids
■ Efficacy (time to first relapse), safety and PK/PD
☐
FPI Q3 2017
Primary endpoint met Q3 2018
■ Data presented at ECTRIMS 2018 and AAN 2019
Published in NEJM 2019; 381:2114-2124
BTD granted by FDA Q4 2018
Filed in EU Q3 2019; US acceptance of filing Q4 2019
"
Approved in US Q3 2020 and EU Q2 2021
NCT02028884
*Trials managed by Chugai (Roche opted-in)
BTD=Breakthrough therapy designation; PK/PD-Pharmacokinetics/Pharmacodynamics; SC-Subcutaneous; ECTRIMS-European Committee for Treatment and Research in Multiple Sclerosis; AAN-American Academy of
Neurology; NEJM New England Journal of Medicine
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NeuroscienceView entire presentation