Clinical Research Studies

This is a phase II, interventional, randomized, double-blind, parallel-group, placebocontrolled, multi-centre study of the efficacy (slowing disease progression), safety, and tolerability of Lu AF82422 in patients with MSA. MSA is a progressive, fatal disorder characterized by autonomic failure and parkinsonism and/or cerebellar involvement. Neuropathologically, MSA is characterized by oligodendroglial inclusions of abnormally aggregated a-synuclein. No disease-modifying therapies are currently available; symptomatic treatment options are limited, and the therapeutic benefit of these therapies is often only transient. Thus, there is a critical unmet need for a treatment that can delay the progression in MSA. a-synuclein is considered a valid target for immunotherapies that aim to neutralize and/or clear toxic a-synuclein species, Lu AF82422 is a human IgG1 mAb that recognizes all major species of a-synuclein and is being developed as a treatment for delaying of disease progression in idiopathic PD and/or MSA. Nonclinical and clinical data of Lu AF82422 supports its potential as a safe and well tolerated treatment to reduce or inhibit seeding of pathological form(s) of a-synuclein, and potentially delay disease progression in MSA.