AFFiRiS Announces FDA Response to its pre-IND Submission for Phase 2 Trial with AFFITOPE® PD01 in Early Parkinson’s Disease Patients

Study start in the US and Europe confirmed for H2 2020

AFFiRiS AG, a clinical-stage biopharmaceutical company developing novel disease-modifying specific active immunotherapies (SAITs) for patients with neurodegenerative diseases, today announced it had received feedback to its pre-Investigational New Drug (”IND”) submission to the U.S. Food and Drug Administration (“FDA”) regarding the planned Phase 2 clinical trial with AFFITOPE® PD01, the Company’s lead candidate for the treatment of early-stage Parkinson’s disease patients. As an outcome to the response, AFFiRiS will proceed with the preparations for the planned phase 2 study and confirms its intended initiation in the US and Europe in the second half of 2020.

The FDA has reviewed the pre-clinical data, the CMC-package, the clinical phase 1 study results and the phase 2 study plan of AFFITOPE® PD01. In its written response, the FDA addressed AFFiRiS’ questions and provided guidance on the design of the planned phase 2 trial.

“We are pleased to have completed the pre-IND process, with the FDA providing helpful guidance for the continued advancement of AFFITOPE® PD01 for the treatment of Parkinson’s disease, an indication with an urgent and significant unmet medical need,” said Noel Barrett, Ph.D., AFFiRiS’ Chief Executive Officer. “We appreciate the FDA’s feedback as we endeavour to provide patients with a potentially disease-modifying immunotherapy utilizing our proprietary patented AFFITOME® technology.”

About AFFITOPE® PD01

AFFITOPE® PD01 is a synthetically produced alpha-synuclein (aSyn)-mimicking peptide based specific active immunotherapy (SAIT) that targets the protein aSyn, which plays a key role in the onset and progression of Parkinson’s Disease. In a phase 1 study program, early Parkinson 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® 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 are diminishing over time.

About AFFiRiS AG

AFFiRiS is a clinical-stage biopharmaceutical company located in Vienna, Austria, that pursues the vision of using the immune system to find and fight human proteins central to the development and progression of neurodegenerative diseases, based on its proprietary patented AFFITOME® technology. The ultimate aim is to improve the lives of patients suffering from these diseases by providing disease-modifying specific active immunotherapies (SAIT). Besides its lead candidate AFFITOPE® PD01, AFFiRiS has programs against multiple system atrophy, Lewy body dementia, and chorea Huntington, which are in pre-clinical development. For further information, please visit www.affiris.com and follow us on LinkedIn.

About the Michael J. Fox Foundation for Parkinson’s Research

As the world’s largest non-profit funder of Parkinson’s research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson’s patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $800 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson’s research, the Foundation forges ground-breaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson’s disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson’s awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world. Learn more at www.michaeljfox.org.

Contact AFFiRiS AG

Dr. Cornelia Kutzer
E cornelia.kutzer(at)affiris.com
W https://www.affiris.com

Media contact

MC Services AG
Julia Hofmann
P +49 89 210228 0
E affiris(at)mc-services.eu

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