AFFiRiS AG announced the start of the Phase I study of its Parkinson´s vaccine candidate PD01A. This vaccine represents aims at disease modification of Parkinson´s rather than addressing symptomatic improvement. PD01A targets a protein called alpha-Synuclein (alpha-syn) which plays a key role in the onset and progression of Parkinson´s. The vaccination aims to educate the immune system to generate antibodies directed against alpha-syn. The trial will be conducted at the Confraternität Privatklinik Josefstadt in Vienna and will involve up to 32 patients.
Dr. Walter Schmidt, CEO of AFFiRiS, comments on the progress of the Parkinson´s project: "Worldwide, for the first time immunotherapy is applied for the treatment of Parkinson´s. It is a so-called "First-in-Man" and "First-in-Kind" trial, because PD01A is the first medication worldwide aiming for clinical efficacy by modulating the metabolic pathway of alpha-syn. Even in its preliminary stages this new treatment concept was highly appreciated, as the renowned Michael J. Fox Foundation assented financial support to a total of USD 1.5 million. Hence, this is one of the few projects outside of the USA considered worthy of support by the foundation."
Since the approval of L-DOPA some 50 years ago, any other therapeutic intervention followed the same concept: the substitution of the neurotransmitter dopamine. Accordingly, all medications for Parkinson´s so far can impact on the symptoms only, but none of them can modify the course of the disease.
Based on today´s scientific understanding, Parkinson´s is caused by deposits of pathological forms of alpha-syn in the brain. A reduction of the brain´s alpha-syn aggregates is believed to have a beneficial impact on the progress of the disease. PD01A shall accomplish that upon the induction of antibodies that are targeting alpha-syn, to neutralize its toxic impact.
Dr. Frank Mattner, CSO of AFFiRiS: "PD01A is based on our AFFITOME-technology, which already identified our lead vaccine developments in the field of Alzheimer´s. This technology delivers not only a single vaccine for the treatment of a certain disease but a whole pool of product candidates with excellent safety profiles and exactly fine tuned specificities. Therefore, we apply our strategy of 'clinical maturation,' meaning that we investigate several vaccines against a certain disease in clinical testing to ensure that the best vaccine for humans will be developed."