- EVRYSDI 2-year FIREFISH Part 2 data show improvement in motor function in infants with Type 1 spinal muscular atrophy (SMA)
- OCREVUS data show its consistent benefit on slowing disease progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS)
- Data for ENSPRYNG in neuromyelitis optica spectrum disorder (NMOSD) reinforce safety and efficacy, including in patients with concomitant autoimmune diseases (CAIDs)
- Data for investigational MS medicine fenebrutinib support its safety profile and high potency
- Additional presentations on investigational programmes, including Alzheimer’s disease and Huntington’s disease, help advance scientific understanding of neurological disorders
“Following
Spinal Muscular Atrophy (SMA)
New 2-year findings from Part 2 of the Phase II/III FIREFISH trial show longer-term efficacy and safety of EVRYSDI in infants with symptomatic Type 1 SMA treated with EVRYSDI. This includes the number of infants able to sit without support for 5 and 30 seconds, a key motor milestone not normally seen in the natural course of the disease, as well as data on event-free survival and reduced hospitalisations.
Additional data being presented across EVRYSDI’s broad clinical trial programme include updated data from the JEWELFISH trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of EVRYSDI in patients previously treated with SMA targeting therapies, as well as updated pooled safety analyses from the FIREFISH, SUNFISH, RAINBOWFISH and JEWELFISH trials.
Multiple Sclerosis (MS)
Neuromyelitis Optica Spectrum Disorder (NMOSD)
New longitudinal, observational data from the CIRCLES study, conducted in collaboration with the
Alzheimer’s Disease (AD)
Gantenerumab is a late-stage investigational anti-beta-amyloid antibody being evaluated in two Phase III studies (GRADUATE I and II), which are the only late-stage AD clinical trials to offer subcutaneous administration. We expect data from the studies in 2022.
Huntington’s Disease (HD)
The full range of data from Roche’s clinical development programme in neuroscience being presented at 2021 AAN include:
Medicine and/or Therapeutic Area | Abstract Title | Presentation Number (type), Session Title Presentation Date Time |
EVRYSDI (risdiplam) for Spinal Muscular Atrophy | FIREFISH Part 2: 24-month Efficacy and Safety of Risdiplam in Infants with Type 1 Spinal Muscular Atrophy (SMA) | P6.062 P6: Neuromuscular Disorders and Clinical Trials |
SUNFISH Part 2: 24-month Efficacy and Safety of Risdiplam in Patients with Type 2 or Non-ambulant Type 3 Spinal Muscular Atrophy (SMA) | P6.060 P6: Neuromuscular Disorders and Clinical Trials | |
JEWELFISH: Safety and Pharmacodynamic Data in Non-naïve Patients with Spinal Muscular Atrophy (SMA) Receiving Treatment with Risdiplam | P6.064 P6: Neuromuscular Disorders and Clinical Trials | |
Pooled Safety Data from the Risdiplam Clinical Trial Development Program | P6.067 P6: Neuromuscular Disorders and Clinical Trials | |
RAINBOWFISH: A study of Risdiplam in Newborns with Presymptomatic Spinal Muscular Atrophy (SMA) | P6.076 P6: Neuromuscular Disorders and Clinical Trials 2 | |
OCREVUS (ocrelizumab) for Multiple Sclerosis | B-Cell Subset Depletion Following Ocrelizumab Treatment in Patients with Relapsing Multiple Sclerosis | P15.206 P15: MS Therapeutics MOA and Safety |
Evolution of Lesions that Shrink or Disappear into Cerebrospinal Fluid (Atrophied T2 Lesion Volume) in Primary-Progressive Multiple Sclerosis: Results from the Phase III ORATORIO Study | P15.151 P15: MS Neuroimaging | |
Recently Diagnosed Early-Stage RRMS: NEDA, ARR, Disability Progression, Serum Neurofilament and Safety: 1-Year Interim Data from the Ocrelizumab Phase IIIb ENSEMBLE Study | P15.099 P15: MS Clinical Trials and Therapeutics | |
Adherence and Persistence to Disease-modifying Therapies for Multiple Sclerosis and Their Impact on Clinical and Economic Outcomes in a | P15.228 P15: | |
Safety of Ocrelizumab in Multiple Sclerosis: Updated Analysis in Patients with Relapsing and Primary Progressive Multiple Sclerosis | P15.203 P15: MS Therapeutics MOA and Safety | |
Fenebrutinib for Multiple Sclerosis | The Safety of Fenebrutinib in a Large Population of Patients with Diverse Autoimmune Indications Supports Investigation in Multiple Sclerosis (MS) | S25.005 (oral presentation) S25: MS and CNS Inflammatory Disease: Emerging Therapeutics and Biomarkers |
Fenebrutinib Demonstrates the Highest Potency of Bruton Tyrosine Kinase Inhibitors (BTKis) in Phase 3 Clinical Development for Multiple Sclerosis (MS) | P15.091 P15: MS Clinical Trials and Therapeutics | |
ENSPRYNG (satralizumab) for Neuromyelitis Optica Spectrum Disorder | Satralizumab in Patients with Neuromyelitis Optica Spectrum Disorder and Concomitant Autoimmune Disease | P2.019 P2: Autoimmune Neurology: Advances in Neuromyelitis Optica Spectrum Disorder (NMOSD) |
Neuromyelitis Optica Spectrum Disorder | Disease Phenotype Correlates with Treatment Change in NMOSD Patients of the CIRCLES Cohort | P2.091 P2: Autoimmune Neurology: Clinical Observations and Advances |
Demographic and Relapse Correlates of Treatment Change in NMOSD Patients: Analysis of the CIRCLES Study | P2.013 P2: Autoimmune Neurology: Advances in Neuromyelitis Optica Spectrum Disorder (NMOSD) | |
Relapse Profile Correlates with Treatment Change in NMOSD Patients of the CIRCLES Cohort | P2.012 P2: Autoimmune Neurology: Advances in Neuromyelitis Optica Spectrum Disorder (NMOSD) | |
Correlates of Rituximab Discontinuation in Patients with NMOSD: a CIRCLES Cohort Analysis | P2.014 P2: Autoimmune Neurology: Advances in Neuromyelitis Optica Spectrum Disorder (NMOSD) | |
Alzheimer’s Disease | Linking Amyloid to Cognition in the Pathogenesis and Treatment of Alzheimer’s Disease: Toward the Development of a “Quantitative A/T/N Model” | P1.052 P1: Aging and Dementia: Biomarkers |
Gantenerumab for Alzheimer’s Disease | Utilization of Home Nursing to Mitigate the Impact of COVID-19 on the Conduct of the Gantenerumab GRADUATE Trials | P1.014 P1: Aging and Dementia: Clinical Trials |
Semorinemab for Alzheimer’s Disease | A Disease Progression Model for Alzheimer’s Disease Predicts Longitudinal Trajectory of CDR-SB Score Across Different Stages of the Disease | P1.061 P1: Aging and Dementia: Neuropsychology |
Huntington’s Disease | Burden of Illness among | P14.043 P14: Huntington’s Disease |
Clinical Characteristics of Late-Onset Huntington’s Disease in North Americans from the Enroll-HD Study | P14.046 P14: Huntington’s Disease | |
Clustering and Prediction of Disease Progression Trajectories in Huntington’s Disease: An Analysis of the Enroll-HD and REGISTRY Database Using a Machine Learning Approach | P14.147 P14: Clinical Trials, Surveys, and Studies in Movement Disorders |
About EVRYSDI™ (risdiplam)
EVRYSDI is a survival of motor neuron 2 (SMN2) splicing modifier designed to treat SMA by increasing production of the survival of motor neuron (SMN) protein. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement. EVRYSDI is administered daily at home in liquid form by mouth or by feeding tube.
The
About OCREVUS® (ocrelizumab)
OCREVUS is the first and only therapy approved for both RMS (including clinically isolated syndrome, RRMS and active, or relapsing, SPMS) and PPMS, with dosing every six months. OCREVUS is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with MS. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved.
OCREVUS is administered by intravenous infusion every six months. The initial dose is given as two 300 mg infusions given two weeks apart. Subsequent doses are given as single 600 mg infusions. With rapidly growing real-world experience and more than 200,000 people treated globally, OCREVUS is the first and only therapy approved for relapsing MS (RMS; including RRMS and active, or relapsing, secondary progressive MS [SPMS], in addition to clinically isolated syndrome [CIS] in the
OCREVUS is approved in 95 countries across
About ENSPRYNG® (satralizumab)
ENSPRYNG, which was designed by Chugai, a member of the
Positive Phase III results for ENSPRYNG, as both monotherapy and in combination with baseline immunosuppressive therapy, suggest that IL-6 inhibition is an effective therapeutic approach for NMOSD. The Phase III clinical development programme for ENSPRYNG includes two studies: SAkuraStar and SAkuraSky.
ENSPRYNG is currently approved in 18 countries, including
ENSPRYNG has been designated as an orphan drug in the
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