Roche Pharmaceutical Development and Sales Overview
R&D focus area Alzheimer's disease
Clinical results for gantenerumab and blood-based biomarkers to be presented at CTAD
Roche
CTAD
Clinical Trials on Alzheimer's Disease
گولا
Pharmaceuticals
gantenerumab
FDA BTD
•
Nearly two decades of scientific investigation with
nearly 7000 patient years on treatment
GRADUATE I/II: Patients with early AD (FDA BTD)
SKYLINE: Patients at risk of, or at the earliest
stages of AD
Brain shuttle gantenerumab
Improve transport of gantenerumab across the
blood brain barrier
Promising Ph I PK data
Platform technology: Ph I trial in MS with a CD20
Anti-tau mABs
Different MoA, targeting tau protein tangles
instead of AB plaques
• Two assets (semorinemab & bepranemab) in Ph II
trials
Roche
Diagnostics
Blood-based biomarker
Elecsys Amyloid Plasma Panel (FDA BDD)
A minimally invasive test to help pre-select
patients for confirmatory testing
Runs on serum work area platforms
CSF-based biomarker
Elecsys Aẞ and pTau CSF
Confirmatory test equivalent to PET scan
Runs on serum work area platforms
Multiple Real World Data (RWD) studies*
*Topics include natural history, predictors of progression in early AD, QoL across the AD continuum and more; Latest RWD study: Delphi study CONCORD-AD 2.0, connecting cohorts to diminish AD
AD=Alzheimer's disease; PK-pharmacokinetics; MS=multiple sclerosis; AB-amyloid beta; BDD-breakthrough device designation; CSF-Cerebrospinal fluid; QoL-quality of life
FDA BDD
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