World Parkinson's Day: AFFiRiS developing PD01 to treat Parkinson's disease, a major unmet medical need

Vienna, Austria, April 9, 2020 - AFFiRiS, a clinical-stage biotechnology company developing novel disease-modifying specific active immunotherapies (SAITs) for patients with neurodegenerative diseases, joins people around the world to raise awareness of Parkinson's disease and the need to increase the efforts in the development of innovative treatment options.

Parkinson's disease is a neurodegenerative disease that results from a progressive loss of nerve cells in the brain. A diagnosis of PD is life-changing for patients, as increasingly debilitating and distressing problems with movement and mental function can develop. As the disease progresses, patients may require assistance for most activities of daily living, which places a profound emotional and physical strain on family members. An estimated 7-10 million people worldwide live with Parkinson's disease.

James Parkinson first described the disease in 1817 as the "Shaking Palsy." Since 1997, World Parkinson's Day has been recognized annually on Parkinson's birthday, April 11^th, and April has been designated as Parkinson's Awareness Month.

"There is a tremendous medical need for therapies that effectively treat and not just manage the symptoms of this increasingly prevalent disease," said Noel Barrett, Ph.D., AFFiRiS's Chief Executive Officer. "Medical innovation requires significant funding, and it is in the interest of the healthcare community and society as a whole that the development of various therapeutic approaches be financially supported by industry partners, financial investors and the public sector to achieve real progress in this field."

Currently available treatments aim to control the symptoms, not stop or reverse disease progression. Parkinson's disease as well as some other neurodegenerative disorders are characterized by the accumulation of the protein alpha-synuclein (aSyn) in neuronal or non-neuronal cells of the brain.

PD01, AFFiRiS's immunotherapy candidate for the treatment of early-stage Parkinson's disease patients, has already demonstrated early signals in a phase 1 study program that the product candidate could potentially stop or slow disease progression by inducing aSyn-specific antibodies that bind to toxic aSyn and subsequently clear it from the brain. A phase 2 trial with PD01 in early-stage Parkinson's disease patients is expected to start in the second half of 2020.

"Never before has so much research been done to target this highly debilitating disease. We believe that we can make a real difference with AFFiRiS' active immunotherapy PD01 by providing a powerful, patient-friendly, once-a-year, cost-effective treatment. We are confident that continuing development of our PD01 drug candidate in a phase 2 study will further confirm the clinical benefits signaled in our phase 1 study series", added Dr. Barrett.

About AFFITOPE(R) PD01:
AFFITOPE(R) PD01 is AFFiRiS' novel immunotherapy candidate for the treatment of early-stage Parkinson's disease patients. PD01 is a synthetically produced alpha-synuclein (aSyn)-mimicking peptide-based specific active immunotherapy (SAIT), identified by the AFFiRiS' AFFITOME(R) technology, that targets the protein aSyn. This protein has been identified as playing a key role in the onset and progression of Parkinson's disease. In a phase 1 study program, early-stage Parkinson's disease patients were observed for up to 48 months with regard to long-term safety, immunological and clinical parameters. The immunotherapy candidate was demonstrated to be well tolerated. AFFITOPE(R) PD01 induced a long-lasting humoral immune response that could be reactivated upon booster application. Clinical scores for PD were stable during the entire study period in the PD01 treated group; however, the study was not designed and not powered to evaluate clinical efficacy. The phase 1 studies were supported by The Michael J. Fox Foundation for Parkinson's Research.

About Parkinson's disease:
Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease and the most common neurodegenerative movement disease. It affects approximately 1% of the population above the age of 60, about 7-10 million people worldwide. PD is a chronic progressive disorder, defined by a combination of motoric and non-motoric syndromes. The hallmark of the disease is a substantial loss of dopaminergic neurons in the brain accompanied by accumulations of filamentous protein inclusions predominantly composed of alpha Synuclein (aSyn). Evidence suggests that the misfolding of the aSyn protein causes inflammation, synaptic dysfunction and finally neuronal cell death. Current therapies target symptoms but fail to modify the underlying neurodegeneration. In addition, these therapies result in varying degrees of side effects, and their beneficial effects diminish over time.

About AFFiRiS AG:
AFFiRiS is a clinical-stage biotechnology company located in Vienna, Austria, with a vision of using the immune system to identify and target human proteins central to the development and progression of neurodegenerative diseases, based on its proprietary patented AFFITOME(R) technology. The Company's ultimate goal is to improve the lives of patients suffering from these diseases by providing disease-modifying specific active immunotherapies (SAIT). With its lead candidate AFFITOPE(R) PD01, AFFiRiS is the leader in active immunotherapies for Parkinson's disease. AFFiRiS' programs against multiple system atrophy, dementia with Lewy bodies, and chorea Huntington are in pre-clinical development.

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