- 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
Basel, 15 June 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that data across its growing neuroscience portfolio will be presented at the 7th Congress of the European Academy of Neurology (EAN) Annual Meeting being held virtually 19-22 June, 2021. These new and encore data demonstrate Roche’s commitment to advancing the clinical understanding of a broad range of neurological disorders with the goal of meeting the needs of people living with both the rarest and most common conditions.“
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 Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We are honoured to work with our partners and the broader community to accelerate progress across our neuroscience portfolio with the goal of transforming the lives of many people living with neurological disorders.”
Spinal Muscular Atrophy (SMA)
Roche will present updated data from across the extensive EVRYSDI™ (risdiplam) clinical development programme, designed to represent a broad spectrum of people living with SMA, including those who have previously been treated with another SMA medication.
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 U.S. and EU. More than 3,000 patients have been treated with EVRYSDI in clinical trials, compassionate use and real-world settings.
Neuromyelitis Optica Spectrum Disorder (NMOSD)
Roche will share three sets of data on people living with NMOSD, including an analysis of the Phase III SAkuraStar and SAkuraSky clinical trials which show ENSPRYNG® (satralizumab) significantly reduced risk of relapse vs placebo in adults with AQP4-IgG seropositive (AQP4-IgG+) NMOSD, with a favourable safety profile.
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) who had a suboptimal response to one or two prior disease-modifying therapies (DMTs). OCREVUS improved work productivity over two years, which correlated with reduced symptom burden and improvement in the physical and psychological impacts of MS.
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)
Roche will present an overview of the CareRing initiative, which engaged AD caregivers to input and provide guidance on trial design and protocol for the Phase IB/IIA Brain Shuttle AD trial, evaluating RG6102 in people with prodromal or mild-to-moderate AD.
RG6102 is a bispecific 2+1 monoclonal antibody that combines investigational gantenerumab with Roche’s Brain Shuttle technology. It is designed to be transported across the blood-brain barrier by engaging the transferrin receptor in order to achieve superior target engagement in the brain.
Huntington’s Disease (HD)
The protocol for a multinational qualitative study sponsored by Roche examining the burden of HD from a multidimensional, generational perspective (SEEING-HD) will be presented. Findings from this study will make an important contribution to advancing evidence-based care to improve the lives of individuals and families affected by HD.
Parkinson’s Disease (PD)
Roche will share three presentations including further results from the Phase II PASADENA study evaluating the safety and efficacy of prasinezumab in early PD. In the PASADENA study, prasinezumab was the first anti-alpha-synuclein antibody to show evidence of slowing clinical decline of PD motor signs and demonstrated a favourable safety profile. These findings warrant further investigations in the recently initiated PADOVA study, studying the effect of prasinezumab in people with early Parkinson’s disease receiving symptomatic therapy. In addition, data from two studies on digital health monitoring in PD will also be presented.
