Affitope PD03A is an investigational vaccine that targets alpha-synuclein, a protein associated with Parkinson’s disease (PD). It is the second alpha-synuclein targeting vaccine that Affiris is developing; the other is Affitope PD01A.
How Affitope PD03A works
Alpha-synuclein (α-Syn) is a protein of unknown function in the brain that is thought to play a key role in the onset and progression of Parkinson’s, clumping together and accumulating in nerve cells and forming Lewy bodies, the pathological hallmark of the disease.
Affitope PD03A promotes the production of α-Syn-targeting antibodies using Affiris’ Affitome technology. This technology involves using short synthetic peptides of altered amino acid sequences to help the immune system generate specific antibodies.
It is hoped that therapies like Affitope PD03A that prevent α-Syn from clumping or that reduce its production in the brain may help prevent the progression of Parkinson’s.
Affitope PD03A in clinical trials
Affitope PD03A is being developed as part of a collaboration between eight academic and industry partners called the SYMPATH project.
A pilot Phase 1 randomized, placebo-controlled bi-center study (NCT02267434) assessed the tolerability and safety of repeated subcutaneous (under the skin) injections of two doses of Affitope PD03A in people with early Parkinson’s.
The trial included 36 participants who were randomized to receive either a high dose (75 micrograms) or low dose (15 micrograms) of Affitope PD03A, or a placebo. A total of five injections were administered, four for priming every four weeks and the fifth as a booster immunization nine months after the first administration.
Primary objectives were to show the safety and tolerability and the ability to generate an immune response of the treatment.
Results of the trial showed that both doses were locally and systemically well-tolerated. There were no drug-related serious adverse events or suspected serious adverse reactions. The main adverse events were local reactions.
The treatment also showed a dose-dependent immune response against itself and cross-reactivity against the α-Syn-targeted epitope over time, showing antibody reactivation nine months after the first dose, with the booster immunization.
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