Roche Pharmaceutical Development and Sales Overview

Enspryng (satralizumab, RG6168, SA237) Anti-IL-6 receptor humanized monoclonal antibody Indication Phase/study # of patients Design " Generalised myasthenia gravis (MG) Myelin oligodendrocyte glycoprotein antibody disease (MOG-AD) Phase III Luminesce N=240 Phase III METEOROID N=152 Autoimmune encephalitis (AE) Phase III CIELO N=152 ARM A: Enspryng plus standard of care ARM B: Placebo plus standard of care ARM A: Enspryng at weeks 0, 2, 4 (loading doses) and maintenance doses q4w ARM B: Placebo ARM A: Enspryng at weeks 0, 2, 4 (loading doses) and maintenance doses q4w ARM B: Placebo Roche Primary endpoint Status Mean change from baseline in total MG-ADL score at week 24 in AChR+ population Orphan Drug Designation granted in US Q1 2021 FPI Q4 2021 Time from randomization to the first occurrence of a MOG-AD relapse FPI Q3 2022 Orphan Drug Designation granted by FDA in Q4 2021 " Efficacy (proportion of participants with mRS score improvement ≥ 1 from baseline and no use of rescue therapy at week 24) and safety FPI Q3 2022 Orphan Drug Designation granted for NMDAR AIE in US Q3 22 CT Identifier In collaboration with Chugai NCT04963270 NCT05271409 NCT05503264 MG-ADL= Myasthenia Gravis Activities of Daily Living; AChR-Acetylcholine receptor; MOG-AD-Myelin Oligodendrocyte Glycoprotein Antibody Disease; AE=Autoimmune encephalitis, mRS-Modified Rankin Scale; NMDAR AIE= Anti- N-Methyl-D-Aspartic Acid Receptor Autoimmune Encephalitis; PK/PD-Pharmacokinetics/Pharmacodynamics 90 00 Neuroscience

View entire presentation