AFFiRiS, a clinical-stage biotechnology company developing novel disease-modifying specific active immunotherapies (SAITs) for patients with neurodegenerative diseases, today announces the award of a new patent by the Chinese National Intellectual Property Administration (CNIPA). The patent covers a group of AFFITOPEs, including PD01, the Company’s lead candidate for the treatment of early-stage Parkinson’s disease patients which is expected to enter clinical phase 2 in the second half of 2020.
AFFiRiS, which has already obtained patents in the United States, Europe, Australia, Canada, India, Japan and South Korea for the same application, thus further expand the geographic coverage of its intellectual property portfolio thanks to this new patent. In addition, the newly granted IP adds to AFFiRiS’ broad patent position covering the treatment of Parkinson's disease, and its product candidate PD01, as well as to its overall body of patents and patent applications, reflecting the excellent competitive profile in the field of neurodegenerative treatments.
“This new patent strengthens the position of our lead candidate, PD01, which we will move into phase 2 of clinical development for the treatment Parkinson’s disease, an indication with an urgent and significant unmet medical need,” said Noel Barrett, Ph.D., AFFiRiS’ Chief Executive Officer. “Importantly, the new IP supports us in the growth of our business in the highly attractive Chinese market.”
AFFiRiS recently received positive FDA responses to its pre-Investigational New Drug (“IND”) submission for the phase 2 trial with AFFITOPE® PD01 in early Parkinson's disease patients. The active immunotherapy candidate PD01 is based on AFFiRiS’ AFFITOPE® technology, which is also covered by this new patent.
The new patent CN 101969989 (also published as WO 2009/103105) describes how AFFiRiS’ AFFITOPE® compounds may prevent and/or treat neurodegenerative disorders characterized by pathological accumulation of alpha-synuclein aggregates, commonly referred to as synucleinopathies, including Parkinson's disease (PD), Parkinson's disease with dementia (PDD) and dementia with Lewy bodies (DLB), as well as Multiple System Atrophy (MSA) or Neurodegeneration with Brain Iron Accumulation type I (NBIA Type I).
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 biotechnology company located in Vienna, Austria, that pursues the 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® technology. The ultimate aim is to improve the lives of patients suffering from these diseases by providing disease-modifying specific active immunotherapies (SAIT). With its lead candidate AFFITOPE® PD01 AFFiRiS is the leader in active immunotherapies for Parkinson’s disease. In addition, AFFiRiS’ programs against multiple system atrophy, dementia with Lewy bodies, and chorea Huntington are in pre-clinical development. For further information, please visit www.affiris.com and follow us on LinkedIn and Twitter.