{"id":473378,"date":"2021-04-08T01:03:18","date_gmt":"2021-04-08T05:03:18","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=473378"},"modified":"2021-04-08T01:03:18","modified_gmt":"2021-04-08T05:03:18","slug":"new-genentech-data-at-2021-aan-highlight-impact-and-breadth-of-expanding-neuroscience-portfolio","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/new-genentech-data-at-2021-aan-highlight-impact-and-breadth-of-expanding-neuroscience-portfolio\/","title":{"rendered":"New Genentech Data at 2021 AAN Highlight Impact and Breadth of Expanding Neuroscience Portfolio"},"content":{"rendered":"

<\/p>\n

New Genentech Data at 2021 AAN Highlight Impact and Breadth of Expanding Neuroscience Portfolio<\/b><\/p>\n

\n\u2013 Evrysdi (risdiplam) 2-year FIREFISH Part 2 data show improvement in motor function in infants with Type 1 spinal muscular atrophy (SMA) \u2013<\/i><\/p>\n

\n\u2013 Ocrevus (ocrelizumab) data show its consistent benefit on slowing disease progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS) \u2013<\/i><\/p>\n

\n\u2013 Data for Enspryng (satralizumab-mwge) in neuromyelitis optica spectrum disorder (NMOSD) reinforce safety and efficacy, including in patients with concomitant autoimmune diseases (CAIDs) \u2013<\/i><\/p>\n

\n\u2013 Data for investigational MS medicine fenebrutinib support its safety profile and high potency \u2013<\/i><\/p>\n

\n\u2013 Additional presentations on investigational programs, including Alzheimer\u2019s disease and Huntington\u2019s disease, help advance scientific understanding of neurological disorders \u2013<\/i><\/p>\n

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE<\/a>)–
\nGenentech, a member of the Roche Group (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 Genentech neuroscience portfolio across six therapeutic areas, including Evrysdi\u2122 (risdiplam) for spinal muscular atrophy (SMA), Ocrevus\u00ae<\/sup> (ocrelizumab) in relapsing and primary progressive multiple sclerosis (RMS and PPMS), investigational Bruton\u2019s tyrosine kinase inhibitor (BTKi) fenebrutinib in Phase III trials for RMS and PPMS, Enspryng\u2122 (satralizumab-mwge) in neuromyelitis optica spectrum disorder (NMOSD), and data from investigational programs in Alzheimer\u2019s disease (AD) and Huntington\u2019s disease (HD).\n<\/p>\n

\n\u201cFollowing U.S. FDA and global approvals for our groundbreaking therapies in SMA and NMOSD, Roche and Genentech\u2019s data at AAN reflect our continued commitment to meaningful therapeutic progress for people living with neurological disorders,\u201d said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. \u201cWe 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.\u201d\n<\/p>\n

Spinal Muscular Atrophy (SMA) <\/b><\/p>\n

\nGenentech will present data from five studies from the Evrysdi clinical development program, which was designed to represent a broad spectrum of people living with SMA. The program 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.\n<\/p>\n

\nNew 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 hospitalizations.\n<\/p>\n

\nAdditional data being presented across Evrysdi\u2019s broad clinical trial program 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.\n<\/p>\n

Multiple Sclerosis (MS)<\/b><\/p>\n

\nGenentech will present 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 suggests 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.\n<\/p>\n

\nGenentech 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.\n<\/p>\n

Neuromyelitis Optica Spectrum Disorder (NMOSD)<\/b><\/p>\n

\nGenentech will present five sets of data on adults living with NMOSD. Data from the Phase III SAkuraStar and SAkuraSky clinical trials reinforce the favorable safety and efficacy of this therapy for those living with NMOSD, including patients with concomitant autoimmune diseases (CAIDs).\n<\/p>\n

\nNew longitudinal, observational data from the CIRCLES study, conducted in collaboration with the Guthy-Jackson Charitable Foundation, a patient advocacy organization dedicated to funding research on NMOSD epidemiology, pathogenesis and treatment, also will be presented. The CIRCLES study explored factors that influence treatment change in people living with NMOSD, including those who have experienced only one relapse.\n<\/p>\n

Alzheimer\u2019s Disease (AD)<\/b><\/p>\n

\nGenentech 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.\n<\/p>\n

\nGantenerumab 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. Data from the studies is expected in 2022.\n<\/p>\n

Huntington\u2019s Disease (HD)<\/b><\/p>\n

\nGenentech also will present an analysis of the Enroll-HD study and REGISTRY database, which 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.\n<\/p>\n

\nThe full range of data from Genentech\u2019s clinical development program in neuroscience being presented at AAN 2021 include:\n<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\nMedicine and\/or
\n
Therapeutic
\n
Area\n<\/p>\n<\/td>\n

\n

\nAbstract Title\n<\/p>\n

\n\u00a0\n<\/p>\n<\/td>\n

\n

\nPresentation Number
\n
(type), Session Title
\n
Presentation Date
\n
Time\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nEvrysdi
\n
(risdiplam)
\n
for Spinal\n<\/p>\n

\nMuscular
\n
Atrophy\n<\/p>\n<\/td>\n

\n

\nFIREFISH Part 2: 24-month Efficacy and Safety of Risdiplam in Infants with Type 1 Spinal Muscular Atrophy (SMA)\n<\/p>\n<\/td>\n

\n

\nP6.062
\n
P6: Neuromuscular Disorders and Clinical Trials\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nSUNFISH Part 2: 24-month Efficacy and Safety of Risdiplam in Patients with Type 2 or Non-ambulant Type 3 Spinal Muscular Atrophy (SMA)\n<\/p>\n<\/td>\n

\n

\nP6.060
\n
P6: Neuromuscular Disorders and Clinical Trials\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nJEWELFISH: Safety and Pharmacodynamic Data in Non-na\u00efve Patients with Spinal Muscular Atrophy (SMA) Receiving Treatment with Risdiplam\n<\/p>\n<\/td>\n

\n

\nP6.064
\n
P6: Neuromuscular Disorders and Clinical Trials\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nPooled Safety Data from the Risdiplam Clinical Trial Development Program\n<\/p>\n<\/td>\n

\n

\nP6.067
\n
P6: Neuromuscular Disorders and Clinical Trials\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nRAINBOWFISH: A study of Risdiplam in Newborns with Presymptomatic Spinal Muscular Atrophy (SMA)\n<\/p>\n<\/td>\n

\n

\nP6.076
\n
P6: Neuromuscular Disorders and Clinical Trials 2\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nOcrevus
\n
(ocrelizumab)
\n
for Multiple
\n
Sclerosis\n<\/p>\n<\/td>\n

\n

\nB-Cell Subset Depletion Following Ocrelizumab Treatment in Patients with Relapsing Multiple Sclerosis\n<\/p>\n<\/td>\n

\n

\nP15.206
\n
P15: MS Therapeutics MOA and Safety\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nEvolution 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\n<\/p>\n<\/td>\n

\n

\nP15.151
\n
P15: MS Neuroimaging\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nRecently Diagnosed Early-Stage RRMS: NEDA, ARR, Disability Progression, Serum Neurofilament and Safety: 1-Year Interim Data from the Ocrelizumab Phase IIIb ENSEMBLE Study\n<\/p>\n<\/td>\n

\n

\nP15.099
\n
P15: MS Clinical Trials and Therapeutics\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nAdherence and Persistence to Disease-modifying Therapies for Multiple Sclerosis and Their Impact on Clinical and Economic Outcomes in a U.S. Claims Database\n<\/p>\n<\/td>\n

\n

\nP15.228
\n
P15: MS Health Care System\/Policy Based Research\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nSafety of Ocrelizumab in Multiple Sclerosis: Updated Analysis in Patients with Relapsing and Primary Progressive Multiple Sclerosis\n<\/p>\n<\/td>\n

\n

\nP15.203
\n
P15: MS Therapeutics MOA and Safety\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nFenebrutinib for
\n
Multiple
\n
Sclerosis\n<\/p>\n<\/td>\n

\n

\nThe Safety of Fenebrutinib in a Large Population of Patients with Diverse Autoimmune Indications Supports Investigation in Multiple Sclerosis (MS)\n<\/p>\n

\n\u00a0\n<\/p>\n

\n\u00a0\n<\/p>\n<\/td>\n

\n

\nS25.005 (oral presentation)
\n
S25: MS and CNS Inflammatory Disease: Emerging Therapeutics and Biomarkers
\n
Tuesday, April 20 at 4:40 pm ET\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nFenebrutinib Demonstrates the Highest Potency of Bruton Tyrosine Kinase Inhibitors (BTKis) in Phase 3 Clinical Development for Multiple Sclerosis (MS)\n<\/p>\n<\/td>\n

\n

\nP15.091\n<\/p>\n

\nP15: MS Clinical Trials and Therapeutics\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nEnspryng
\n
(satralizumab-mwge)
\n
for Neuromyelitis
\n
Optica
\n
Spectrum
\n
Disorder\n<\/p>\n

\n\u00a0\n<\/p>\n<\/td>\n

\n

\nSatralizumab in Patients with Neuromyelitis Optica Spectrum Disorder and Concomitant Autoimmune Disease\n<\/p>\n<\/td>\n

\n

\nP2.019
\n
P2: Autoimmune Neurology: Advances in Neuromyelitis Optica Spectrum Disorder (NMOSD)\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nNeuromyelitis
\n
Optica
\n
Spectrum
\n
Disorder\n<\/p>\n<\/td>\n

\n

\nDisease Phenotype Correlates with Treatment Change in NMOSD Patients of the CIRCLES Cohort\n<\/p>\n<\/td>\n

\n

\nP2.091
\n
P2: Autoimmune Neurology: Clinical Observations and Advances\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nDemographic and Relapse Correlates of Treatment Change in NMOSD Patients: Analysis of the CIRCLES Study\n<\/p>\n

\n\u00a0\n<\/p>\n<\/td>\n

\n

\nP2.013
\n
P2: Autoimmune Neurology: Advances in Neuromyelitis Optica Spectrum Disorder (NMOSD)\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nRelapse Profile Correlates with Treatment Change in NMOSD Patients of the CIRCLES Cohort\n<\/p>\n

\n\u00a0\n<\/p>\n

\n\u00a0\n<\/p>\n<\/td>\n

\n

\nP2.012
\n
P2: Autoimmune Neurology: Advances in Neuromyelitis Optica Spectrum Disorder (NMOSD)\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nCorrelates of Rituximab Discontinuation in Patients with NMOSD: a CIRCLES Cohort Analysis\n<\/p>\n

\n\u00a0\n<\/p>\n

\n\u00a0\n<\/p>\n<\/td>\n

\n

\nP2.014
\n
P2: Autoimmune Neurology: Advances in Neuromyelitis Optica Spectrum Disorder (NMOSD)\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nAlzheimer\u2019s
\n
Disease\n<\/p>\n<\/td>\n

\n

\nLinking Amyloid to Cognition in the Pathogenesis and Treatment of Alzheimer\u2019s Disease: Toward the Development of a \u201cQuantitative A\/T\/N Model\u201d\n<\/p>\n<\/td>\n

\n

\nP1.052
\n
P1: Aging and Dementia: Biomarkers\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nGantenerumab
\n
for Alzheimer\u2019s
\n
Disease\n<\/p>\n<\/td>\n

\n

\nUtilization of Home Nursing to Mitigate the Impact of COVID-19 on the Conduct of the Gantenerumab GRADUATE Trials\n<\/p>\n<\/td>\n

\n

\nP1.014
\n
P1: Aging and Dementia: Clinical Trials\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nSemorinemab for Alzheimer\u2019s
\n
Disease\n<\/p>\n<\/td>\n

\n

\nA Disease Progression Model for Alzheimer\u2019s Disease Predicts Longitudinal Trajectory of CDR-SB Score Across Different Stages of the Disease\n<\/p>\n<\/td>\n

\n

\nP1.061
\n
<\/b>P1:Aging and Dementia: Neuropsychology<\/p>\n<\/td>\n<\/tr>\n

\n

\nHuntington\u2019s
\n
Disease\n<\/p>\n<\/td>\n

\n

\nBurden of Illness among U.S. Medicare Beneficiaries with Late-onset Huntington\u2019s Disease\n<\/p>\n<\/td>\n

\n

\nP14.043
\n
P14: Huntington\u2019s Disease\n<\/p>\n

\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nClinical Characteristics of Late-onset Huntington\u2019s Disease in North Americans from the Enroll-HD Study\n<\/p>\n<\/td>\n

\n

\nP14.046
\n
P14: Huntington\u2019s Disease\n<\/p>\n

\n\u00a0\n<\/p>\n<\/td>\n<\/tr>\n

\n

\nClustering and Prediction of Disease Progression Trajectories in Huntington\u2019s Disease: An Analysis of the Enroll-HD and REGISTRY Database Using a Machine Learning Approach\n<\/p>\n<\/td>\n

\n

\nP14.147
\n
P14: Clinical Trials, Surveys, and Studies in Movement Disorders\n<\/p>\n<\/td>\n<\/tr>\n<\/table>\n

About spinal muscular atrophy<\/b><\/p>\n

\nSpinal muscular atrophy (SMA) is a severe, progressive neuromuscular disease that can be fatal. It affects approximately one in 10,000 babies and is the leading genetic cause of infant mortality. SMA is caused by a mutation of the survival motor neuron 1 (SMN1) gene, which leads to a deficiency of SMN protein. This protein is found throughout the body and is essential to the function of nerves that control muscles and movement. Without it, nerve cells cannot function correctly, leading to muscle weakness over time. Depending on the type of SMA, an individual\u2019s physical strength and their ability to walk, eat or breathe can be significantly diminished or lost.\n<\/p>\n

About Evrysdi\u2122 (risdiplam)<\/b><\/p>\n

\nEvrysdi is a survival of motor neuron 2 (SMN2) splicing modifier designed to treat SMA by increasing and sustaining 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.\n<\/p>\n

\nThe U.S. Food and Drug Administration (FDA) approved Evrysdi for the treatment of SMA in adults and children 2 months of age and older in August of 2020. In March 2021, the European Commission (EC) approved Evrysdi for the treatment of 5q SMA in patients 2 months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. Evrysdi has been approved in 38 countries and submitted in a further 33 countries.\n<\/p>\n

\nEvrysdi is currently being evaluated in four multicenter trials in people with SMA:\n<\/p>\n