Patent adds to company's robust portfolio covering clinical stage lead development candidate PD01
VIENNA, AUSTRIA - EQS Newswire - March 3, 2020 - 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
AFFiRiS recently received
positive FDA responses to its pre-Investigational New Drug ("IND")
submission for the phase 2 trial with AFFITOPE(R) PD01 in early Parkinson's
disease patients. The active immunotherapy candidate PD01 is based on AFFiRiS'
AFFITOPE(R) technology, which is also covered by this new patent.
The new patent CN 101969989
(also published as WO 2009/103105) describes how AFFiRiS' AFFITOPE(R) 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).
The issuer is solely responsible for the content of this announcement.
About AFFITOPE(R) PD01:
AFFITOPE(R) 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(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 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(R)
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(R) 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
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About Parkinson's disease: