Affiris Announces Phase 2 Study of Potential Parkinson’s Vaccine

Affiris is preparing for a Phase 2 clinical trial to test Affitope (PD01A), an experimental medicine that, if successful, could lead to a vaccine against  Parkinson’s disease.

Affitope triggers the production of antibodies — molecules that recognize specific targets — against alpha-synuclein, a protein found in the brain that may be involved in transmitting information between neurons. While its precise function remains unknown, in the context of Parkinson’s disease toxic forms of this protein contribute to the death of neurons by clumping together into spherical structures called Lewy bodies.

By encouraging one’s body to develop its own defenses against molecules that contribute to Parkinson’s, Affitope works like a vaccine against the disease. In this way, a limited number of doses of Affitope might be able to replace other medicines that must be taken on a continual basis.

In its series of Phase 1 trials (NCT01568099, NCT01885494, NCT02618941, NCT02758730, and NCT02216188), Affitope showed long-term safety, effectiveness and tolerability, and appeared to provide the longest benefit when given as an initial injection, followed by a booster, as is done now for tetanus.

In general, vaccines work by creating a cellular “memory” of defense against the target molecule. As with other memories, this one fades with time. The booster shot serves as a “reminder.”

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“Patients with neurodegenerative diseases such as Parkinson’s disease face an all-too-predictable future and are in urgent need of therapies that alter the course of disease progression. Although there are many treatments available to manage the devastating symptoms, sadly none of these acts on the underlying cause of the disease. However, AFFiRiS’ unique immunological approach provides a disease-modifying therapy with an excellent competitive [profile] in the field of neurodegenerative treatments,” Rossella Medori, MD, chief medical officer at AFFiRiS, said in a press release.

Although vaccinating against Parkinson’s is not a widespread strategy, Affiris is not alone. In late 2018, United Neuroscience developed its own candidate molecule to induce an immune response against alpha-synuclein, and Prothena is currently conducting a Phase 2 trial of an injectable antibody against alpha-synuclein (NCT03100149).

Founded in 2003, Affiris has been dedicated to using the immune system to cure neurodegenerative diseases. They currently investigate therapies for Parkinson’s, Alzheimer’s, multiple system atrophy, dementia with Lewy bodies, and Huntington’s disease.

Affiris has not announced when or where its upcoming Phase 2 Affitope trial will take place.