Genentech's Gantenerumab Missed Primary Endpoints in P-III (GRADUATE I & II) Studies for Early Alzheimer’s Disease
Shots:
- The P-III (GRADUATE I & II) studies evaluating gantenerumab vs PBO in a ratio (1:1) in 1965 patients with MCI due to AD across 30 countries. The therapy was discovered in collaboration with MorphoSys
- The trial failed to meet its 1EPs i.e., a relative reduction of clinical decline in both trials (8% & 6%), CDR-SB measures incl. cognitive & functional change across 6 areas while the 2EPs incl., change in disease severity, assessment of therapeutic levels, the incidence of AEs, disease biomarkers & scans
- The level of beta-amyloid removal by gantenerumab was lower, and the incidence of ARIA-E (25%), and the incidence of isolated ARIA-H were balanced across both arms. The results are expected to be presented at CTAD 2022
Ref: Businesswire | Image: Genentech
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
