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Safety and Tolerability of Active Immunotherapy Targeting α-Synuclein with PD03A in Patients with Early Parkinson’s Disease: A Randomized, Placebo-Controlled, Phase 1 Study by Werner Poewe; Dieter Volc; Klaus Seppi; Rossella Medori; Petra Lührs; Alexandra Kutzelnigg; Atbin Djamshidian; Caroline Thun-Hohenstein; Wassilios G. Meissner; Olivier Rascol; Achim Schneeberger; Günther Staffler; Werner Poewe; Klaus Seppi; Atbin Djamshidian; Roberto deMarzi; Beatrice Heim; Stephanie Mangesius; Raphaela Stolz; Katarzyna Wachowicz; Dieter Volc; Caroline Thun-Hohenstein; Constanze Riha; Achim Schneeberger; Vera Bürger; Gergana Galabova; on behalf of the AFF011 investigators; AFF011 study investigators: is a Medicine article available to read on EtoBox.

What is Safety and Tolerability of Active Immunotherapy Targeting α-Synuclein with PD03A in Patients with Early Parkinson’s Disease: A Randomized, Placebo-Controlled, Phase 1 Study about?

## Background: Immunotherapies targeting α-synuclein aim to limit its extracellular spread in the brain and prevent progression of pathology in Parkinson’s disease (PD). PD03A is a specific active immunotherapy (SAIT) involving immunization with a short peptide formulation. ## Objective: This phase 1 study characterized the safety and tolerability of PD03A in patients with early PD. A key secondary objective was to evaluate immunological activity following immunization. ## Methods: This was a phase 1 study of two different doses of PD03A versus placebo in PD patients. Patients were randomized (1:1:1) to receive four priming plus one booster vaccination of PD03A 15μg, PD03A 75μg or placebo and were followed for 52 weeks. ## Results: Overall, 36 patients were randomized, of which 35 received five immunizations and completed the study. All patients experienced at least one adverse event. Transient local injection site reactions affected all but two patients; otherwise most AEs were considered unrelated to study treatment. A substantial IgG antibody response against PD03 was observed with a maximum titer achieved at Week-12. Differences in titers between both active groups versus place

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Author

Werner Poewe; Dieter Volc; Klaus Seppi; Rossella Medori; Petra Lührs; Alexandra Kutzelnigg; Atbin Djamshidian; Caroline Thun-Hohenstein; Wassilios G. Meissner; Olivier Rascol; Achim Schneeberger; Günther Staffler; Werner Poewe; Klaus Seppi; Atbin Djamshidian; Roberto deMarzi; Beatrice Heim; Stephanie Mangesius; Raphaela Stolz; Katarzyna Wachowicz; Dieter Volc; Caroline Thun-Hohenstein; Constanze Riha; Achim Schneeberger; Vera Bürger; Gergana Galabova; on behalf of the AFF011 investigators; AFF011 study investigators:

Publisher

IOS Press

Published

2021

Language

EN

Field

Medicine (Health Sciences)