- Data for EVRYSDI reinforce safety profile and efficacy in a broad spinal muscular atrophy (SMA) population, following recent EU approval
- Data for ENSPRYNG in neuromyelitis optica spectrum disorder (NMOSD) build on safety profile and efficacy following recent CHMP opinion, including in adults with concomitant autoimmune diseases (CAIDs)
- OCREVUS data continue to show consistent benefit on slowing disease progression in relapsing MS (RMS) and primary progressive MS (PPMS)
- Additional presentations in Alzheimer’s disease (AD), Huntington’s disease (HD) and Parkinson’s disease (PD) continue to contribute to understanding of these complex neurological disorders
Our data at EAN and recent European regulatory milestones for EVRYSDI and ENSPRYNG reflect our continued commitment to discovering and developing breakthrough medicines for challenging neurological conditions.” said
Spinal Muscular Atrophy (SMA)
Among the five abstracts featured, new data includes 12-month safety, pharmacodynamic and interim exploratory efficacy data from the JEWELFISH study of EVRYSDI in people previously treated with SMA-targeting therapies across a broad range of ages (1–60 years), SMA types (1–3) and SMN2 copy number (1-5).
Data from SUNFISH Part 2 supporting the safety profile and efficacy of EVRYSDI in people aged 2-25 years with SMA Types 2 or non-ambulant Type 3 after two years of treatment will also be shared, as well as updated 2-year safety and efficacy data from the pivotal FIREFISH Parts 1 and 2 showing continued improvements in survival and motor milestones in infants aged one to seven months with Type 1 SMA.
In addition, preliminary safety and efficacy data from the RAINBOWFISH study of EVRYSDI treatment in pre-symptomatic babies from birth to six weeks will be presented, along with longer-term safety data from a separate pooled analysis of the FIREFISH, SUNFISH, JEWELFISH and RAINBOWFISH trials.
EVRYSDI, the first and only at home SMA treatment, is now approved in 42 countries, including the
Neuromyelitis Optica Spectrum Disorder (NMOSD)
A separate pooled data analysis from the SAkura studies will also be presented, reinforcing favourable safety and efficacy of ENSPRYNG in people with NMOSD, including those with concomitant autoimmune diseases (CAIDs). Results from a new claims-based algorithm to identify people with NMOSD and NMOSD relapses in German claims data will also be shared.
ENSPRYNG is currently approved in 24 countries and has received a positive CHMP opinion as the first and only subcutaneous treatment for adults and adolescents with AQP4-IgG seropositive NMOSD in the EU, enabling home dosing by a person with NMOSD or their care partner.
Multiple Sclerosis (MS)
Four OCREVUS® (ocrelizumab) presentations will be shared, including an analysis of the Phase IIIb CASTING study in people with relapsing-remitting MS (RRMS)
Data from a separate subgroup analysis of the CASTING study will also be presented, continuing to show a favourable benefit-risk profile for OCREVUS and comparable safety outcomes regardless of age, type, or number of prior DMTs.
In addition, data from the OPERA and ORATORIO Phase III studies and their open-label extensions will be shared. A pooled analysis of the OPERA I and II studies, showed that OCREVUS reduced cerebellar atrophy in relapsing MS (RMS), compared with interferon beta-1a (IFN). An analysis of the open-label extension studies demonstrated that individuals initially treated with OCREVUS maintained lower cerebellar volume loss relative to baseline in both RMS and primary progressive MS (PPMS) during the open-label extension periods vs. those initially treated with comparators. OCREVUS is the first and only therapy approved for both RMS and PPMS with twice-yearly dosing, with over 200,000 patients treated globally.
Finally, a late-breaking oral abstract on risk factors for developing symptomatic or serious COVID-19 in patients treated with OCREVUS will be presented.
Alzheimer’s Disease (AD)
RG6102 is a bispecific 2+1 monoclonal antibody that combines investigational gantenerumab with Roche’s
Huntington’s Disease (HD)
The protocol for a multinational qualitative study sponsored by
Parkinson’s Disease (PD)
The full range of data from Roche’s clinical development programme in neuroscience being presented at EAN include:
Medicine and/or Therapeutic Area | Abstract Title | Presentation Number (type), Session Title Presentation Date Time |
EVRYSDI (risdiplam) for Spinal Muscular Atrophy | FIREFISH Parts 1 and 2: 24-Month Safety and Efficacy of Risdiplam in Type 1 SMA | EPR213 Motor neurone diseases 2 13:15 – 14:00 |
JEWELFISH: 12-month safety, pharmacodynamic and exploratory efficacy of risdiplam in non-naïve patients with SMA | EPR213 Motor neurone diseases 2 13:15 – 14:00 | |
Pooled safety data from the risdiplam clinical trial development program | EPR213 Motor neurone diseases 2 13:15 – 14:00 | |
RAINBOWFISH: A study of risdiplam in infants with presymptomatic SMA | EPR213 Motor neurone diseases 2 13:15 – 14:00 | |
SUNFISH Part 2: 24-month efficacy and safety of risdiplam in patients with Type 2 or non-ambulant Type 3 SMA | OS3005 Motor neurone disease 2 17:00 – 18:15 | |
ENSPRYNG (satralizumab) for Neuromyelitis Optica Spectrum Disorder | Satralizumab in adults with AQP4-IgG seropositive NMOSD: Efficacy and safety results from the phase 3 SAkura studies | OS3003 Multiple Sclerosis: NMOSD 16:45 – 18:15 |
Satralizumab in patients with neuromyelitis optica spectrum disorder (NMOSD) and concomitant autoimmune disease | OS3003 Multiple Sclerosis: NMOSD 16:45 – 18:15 | |
Neuromyelitis Optica Spectrum Disorder | Claims-based algorithm to identify NMOSD patients and relapses in German claims data | EPO222 MS and related disorders 3 19:30 – 20:15 |
OCREVUS (ocrelizumab) for Multiple Sclerosis | Effect of Ocrelizumab on Cerebellar Atrophy in RMS and PPMS: Results from OPERA I/OPERA II and ORATORIO | OS1016 Multiple Sclerosis: Clinical studies 17:00 – 18:30 |
Safety of Ocrelizumab in Patients With RRMS With Suboptimal Response to Prior DMTs: Data From the CASTING Study | OS1016 Multiple Sclerosis: Clinical studies 17:00 – 18:30 | |
Improvements in Work Productivity and Activity Impairment in OCR-treated patients with RRMS: 2-year CASTING study data | EPR108 MS and related disorders 1 12:00 – 12:45 | |
COVID-19 risk factors in people with multiple sclerosis treated with ocrelizumab | OS4004 08:30 – 08:45 | |
RG6102 for Alzheimer’s Disease | Engaging the Alzheimer’s disease (AD) CareRing caregiver community in designing the Phase IB/IIA Brainshuttle AD trial | EPO323 Neurology and arts, History of neurology, Education in neurology 14:00 – 14:45 |
Huntington’s Disease | A Multinational Qualitative Study Examining the Intergenerational Burden of Huntington’s Disease (part of SEEING-HD) | EPO216 Cognitive neurology/neuropsychology 2 19:30 – 20:15 |
Parkinson’s Disease | Phase II PASADENA Part 1 Week 52 results: Evaluating safety and efficacy of prasinezumab in early Parkinson's disease | OS2010 Movement Disorders: Treatment 15:00 - 16:30 |
Roche Parkinson’s Disease Mobile Application v2 detects potential disease modifying effect of prasinezumab | OS2010 Movement Disorders: Treatment 15:00 - 16:30 | |
Reliability and validity of passively measured gait gestures from smartphones and smartwatches in Parkinson’s disease | OS2004 Movement Disorders: Clinical 17:00 - 18:30 |
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 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 included two studies: SAkuraStar and SAkuraSky.
ENSPRYNG is currently approved in 24 countries, including
ENSPRYNG has been designated as an orphan drug in 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.
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