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Lundbeck's Phase 3 MASCOT trial will test if amlenetug slows Multiple System Atrophy progression in U.S., EU, and Japan.
Lundbeck will present the Phase 3 MASCOT trial design for amlenetug, an investigational antibody targeting α-synuclein in Multiple System Atrophy (MSA), at the 2025 International Congress of Parkinson's Disease and Movement Disorders.
The trial, ongoing in the U.S., EU, and Japan, uses an adaptive Bayesian approach to evaluate whether amlenetug can slow MSA progression, a rare, rapidly advancing disorder with no approved treatments.
Amlenetug has Orphan Drug Designation in the U.S. and EU, and SAKIGAKE status in Japan.
Patient and caregiver insights from a prior Phase 2 trial informed the design, emphasizing MSA’s severe impact on daily life.
El ensayo MASCOT de fase 3 de Lundbeck probará si amlenetug ralentiza la progresión de la atrofia del sistema múltiple en los Estados Unidos, la UE y Japón.