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Press Release: New Roche data at 2021 AAN highlight impact and breadth of expanding neuroscience portfolio

04/08/2021 | 01:00am
 
   -- 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 
 
 
 
   Basel, 8 April 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced 
that new data for its approved and investigational medicines for the 
treatment of neurological disorders will be presented at the 73rd 
American Academy of Neurology (AAN) Annual Meeting being held virtually 
April 17-22, 2021. These new data include 23 abstracts highlighting the 
expanding Roche neuroscience portfolio across six therapeutic areas, 
including EVRYSDI(TM) (risdiplam) for spinal muscular atrophy (SMA), 
OCREVUS(R) (ocrelizumab) in relapsing and primary progressive multiple 
sclerosis (RMS and PPMS), investigational Bruton's tyrosine kinase 
inhibitor (BTKi) fenebrutinib in Phase III trials for RMS and PPMS, 
ENSPRYNG(R) (satralizumab) in neuromyelitis optica spectrum disorder 
(NMOSD), and data from investigational programmes in Alzheimer's disease 
(AD) and Huntington's disease (HD). 
 
 
 
   "Following U.S. FDA and global approvals for our groundbreaking 
therapies in SMA and NMOSD, Roche's data at AAN reflect our continued 
commitment to meaningful therapeutic progress for people living with 
neurological disorders," said Levi Garraway, M.D., Ph.D., Roche's Chief 
Medical Officer and Head of Global Product Development. "We are proud to 
collaborate with patient advocates, academia, industry and the broader 
healthcare community through cutting-edge research and partnerships to 
advance the scientific understanding of neurological conditions, which 
have historically been among the hardest disorders to study, diagnose 
and treat." 
 
 
 
   Spinal Muscular Atrophy (SMA) 
 
   Roche will present data from five studies from the EVRYSDI clinical 
development programme, which was designed to represent a broad spectrum 
of people living with SMA. The programme includes infants aged 2 months 
to adults aged 60 years with varying degrees of disability, including 
people with scoliosis or joint contractures, and those previously 
treated for SMA with another medication. 
 
 
 
   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) 
 
   Roche will be presenting data from its MS Franchise, including five 
presentations covering OCREVUS and results from studies on the 
investigational BTKi fenebrutinib. Real-world data continue to show the 
highest persistence and adherence to OCREVUS, the only MS therapy with a 
twice-yearly dosing schedule, over one year compared to other 
disease-modifying therapies (DMTs). Additionally, a post-hoc analysis of 
the ORATORIO Phase III PPMS study will be presented, which suggest 
OCREVUS significantly slowed atrophied T2-lesion volume accumulation, a 
subclinical measure of disease progression. Furthermore, interim 
analysis of the open-label Phase IIIb ENSEMBLE study shows OCREVUS 
treatment provided consistent benefit over one year in patients who were 
recently diagnosed with relapsing-remitting multiple sclerosis (RRMS) 
and had not received prior DMT. 
 
 
 
   Roche is continuing to advance the science in MS and is exploring the 
investigational medicine fenebrutinib. Data from fenebrutinib, a highly 
selective, non-covalent, reversible oral BTKi, support its safety 
profile in several autoimmune diseases and high potency, which is 
encouraging for the ongoing Phase III studies in RMS and PPMS. 
Fenebrutinib is a dual inhibitor of both B-cell and myeloid lineage-cell 
activation, which may offer a novel approach to slowing disease 
progression by targeting both acute and chronic inflammatory aspects of 
MS. 
 
 
 
   Neuromyelitis Optica Spectrum Disorder (NMOSD) 
 
   Roche will present five sets of data on adults living with NMOSD. Data 
from the Phase III SAkuraStar and SAkuraSky clinical trials reinforce 
the favourable safety and efficacy of this therapy for those living with 
NMOSD, including patients with concomitant autoimmune diseases (CAIDs). 
 
 
 
   New longitudinal, observational data from the CIRCLES study, conducted 
in collaboration with the Guthy-Jackson Charitable Foundation, a patient 
advocacy organisation dedicated to funding research on NMOSD 
epidemiology, pathogenesis and treatment, will also be presented. The 
CIRCLES study explored factors that influence treatment change in people 
living with NMOSD, including those who have experienced only one 
relapse. 
 
 
 
   Alzheimer's Disease (AD) 
 
   Roche will present data on the increased use of home nursing 
capabilities in the Phase III GRADUATE studies of gantenerumab during 
the COVID-19 pandemic, which enabled home-bound trial participants to 
continue dosing to maintain medicine exposure. 
 
 
 
   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) 
 
   Roche will also present an analysis of the Enroll-HD study and REGISTRY 
database, which will highlight the role that genetic factors and medical 
history may have in predicting the rate of disease progression in HD. 
These data may help advance the understanding of HD and inform future 
treatment approaches for this rare, neurological condition. 
 
   The full range of data from Roche's clinical development programme in 
neuroscience being presented at 2021 AAN include: 
 
 
 
 
Medicine and/or          Abstract Title                                  Presentation Number 
 Therapeutic                                                              (type), Session Title 
 Area                                                                     Presentation Date 
                                                                          Time 
-----------------------  ----------------------------------------------  ------------------------------- 
EVRYSDI                  FIREFISH Part 2: 24-month Efficacy              P6.062 
 (risdiplam)              and Safety of Risdiplam in Infants              P6: Neuromuscular Disorders 
 for Spinal               with Type 1 Spinal Muscular Atrophy             and Clinical Trials 
 Muscular Atrophy         (SMA) 
-----------------------  ----------------------------------------------  ------------------------------- 
                         SUNFISH Part 2: 24-month Efficacy               P6.060 
                          and Safety of Risdiplam in Patients             P6: Neuromuscular Disorders 
                          with Type 2 or Non-ambulant Type                and Clinical Trials 
                          3 Spinal Muscular Atrophy (SMA) 
-----------------------  ----------------------------------------------  ------------------------------- 
                         JEWELFISH: Safety and Pharmacodynamic           P6.064 
                          Data in Non-naïve Patients                 P6: Neuromuscular Disorders 
                          with Spinal Muscular Atrophy (SMA)              and Clinical Trials 
                          Receiving Treatment with Risdiplam 
                         ----------------------------------------------  ------------------------------- 
                         Pooled Safety Data from the Risdiplam           P6.067 
                          Clinical Trial Development Program              P6: Neuromuscular Disorders 
                                                                          and Clinical Trials 
                         ----------------------------------------------  ------------------------------- 
                         RAINBOWFISH: A study of Risdiplam               P6.076 
                          in Newborns with Presymptomatic                 P6: Neuromuscular Disorders 
                          Spinal Muscular Atrophy (SMA)                   and Clinical Trials 
                                                                          2 
-----------------------  ----------------------------------------------  ------------------------------- 
OCREVUS (ocrelizumab)    B-Cell Subset Depletion Following               P15.206 
 for Multiple             Ocrelizumab Treatment in Patients               P15: MS Therapeutics 
 Sclerosis                with Relapsing Multiple Sclerosis               MOA and Safety 
-----------------------  ----------------------------------------------  ------------------------------- 
                         Evolution of Lesions that Shrink                P15.151 
                          or Disappear into Cerebrospinal                 P15: MS Neuroimaging 

(MORE TO FOLLOW) Dow Jones Newswires

April 08, 2021 01:00 ET (05:00 GMT)

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