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PRESS RELEASE: The Lancet Neurology publishes positive results of AFFiRiS' Phase 1 trial with PD01A in Parkinson's disease patients

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DGAP-News: AFFiRiS AG / Key word(s): Study results
The Lancet Neurology publishes positive results of AFFiRiS' Phase 1 trial
with PD01A in Parkinson's disease patients

2020-06-18 / 09:05
The issuer is solely responsible for the content of this announcement.

*The Lancet Neurology publishes positive results of AFFiRiS' Phase 1 trial
with PD01A in Parkinson's disease patients*

· *Repeated immunisation with PD01A is safe and well-tolerated over an
extended time period*

· *Active immunisation with PD01A resulted in a substantial aSyn-specific
antibody response and memory effect*

· *This antibody response was associated with a substantial reduction in
CSF oligomeric aSyn protein *

· *Results represent long-term data from a first-in-human study series
using specific active immunotherapy (SAIT) AFFITOPE(R) PD01A*

*Vienna, Austria, June 18, 2020* - AFFiRiS AG, a clinical-stage
biotechnology company developing novel disease-modifying specific active
immunotherapies (SAITs), today announced that detailed results of the phase
1 clinical program with its lead candidate PD01 in early Parkinson's disease
(PD) patients were published in the peer-reviewed journal The Lancet
Neurology (https://doi.org/10.1016/S1474-4422(20)30136-8 [1]). The results
of the long-term phase 1 trial series demonstrated that repeated
immunisation with PD01A is safe and well-tolerated over an extended period
of time. The data showed that active immunisation with PD01A leads to a
positive antibody response specific for alpha-synuclein (aSyn), a protein
that is believed to contribute to the pathogenesis of Parkinson's disease.
Active immunisation also resulted in a substantial reduction (mean of 51%)
in the levels of aSyn oligomers in the CSF of patients who received the high
dose therapy, which is interpreted as a sign of _in vivo_ target engagement.

Extensive evidences support the role of soluble aSyn oligomers as a
causative factor in the development of Parkinson's disease and reducing the
levels of aSyn oligomers could potentially have disease-modifying benefit in
PD patients.

In the trial, the patients were randomised to receive four immunisations
with two different doses of AFFiRiS' drug candidate and were followed for at
least 3.5 years to assess the safety of the PD01A immunotherapeutic. In
particular, this was the first study to assess the feasibility and safety of
a specific active immunotherapy against aSyn.

The results of this phase 1 study demonstrated that immunisation with PD01A
is safe when repeatedly administered and was well-tolerated over an extended
time period. With the exception of expected local injection site reactions,
most AEs were considered unrelated to study treatment. No patient
discontinued due to treatment emergent adverse events. Immunisation resulted
in a significant increase in IgG antibody against the immunizing AFFITOPE(R)
PD01 peptide already after three priming injections with a maximum titre
being achieved at Week 12. This led to a specific humoral immune response
against the aSyn target epitope. Moreover, the priming immunisations
resulted in a substantial memory effect for the aSyn target epitope as
evidenced by the reactivation and augmentation of the antibody response
following booster immunisations. This resulted in the persistence of the
immune response until study end.

Although the study was not designed and not powered to evaluate clinical
efficacy, clinical signals of efficacy were observed. In particular,
MDS-UPDRS motor scores were generally stable across the study series, in
contrast to published data which reports a worsening in MDS-UPDRS scores in
a similar patient population.

"The PD01A safety profile and the substantial sustained aSyn antibody
response targeting both the toxic oligomeric and fibrillar form of aSyn,
which are believed to contribute to the pathology of PD, may offer a
promising strategy for long-term management of PD, addressing an urgent
medical need," said *Dieter Volc M.D., principal investigator of the study
series and Head of the Parkinson Center at the Privatklinik Confraternitaet,

"The encouraging results, including signals for clinical efficacy, warrant
the further development of our drug for the treatment of PD in a phase 2
clinical trial," commented *Noel Barrett, Ph.D., AFFiRiS' Chief Executive
Officer*. "Potentially, specific active immunisation approaches such as with
PD01A might overcome the limitations of passive antibody infusion approaches
for PD, caused by their short _in vivo_ half-lives, and circumvent frequent
and high treatment costs by stimulating a self-produced, long-lasting immune

The data published in The Lancet Neurology is the first report of an active
anti-aSyn immunotherapy associated with reduction of CSF aSyn oligomers in
PD patients and points to the possible development of this protein as a
potential biomarker for disease progression.

The phase 1 trial was supported by The Michael J. Fox Foundation for
Parkinson's Research. A phase 2 trial in early-stage Parkinson's disease
patients is in preparation and expected to start in the second half of 2020,
depending on the emerging COVID-19 situation.

*About the phase 1 clinical trial study: *

The study was a patient-blinded, single-centre, randomised, first-in-human
study followed by three consecutive extensions. 24 Parkinson's disease
patients were randomised to receive four immunisations with either 15µg or
75µg PD01A and were followed for at least 3.5 years. For the first booster
injection, patients were re-randomised to receive PD01A doses of 15µg or
75µg. All patients received a second booster injection of 75µg. The primary
objective was to assess the safety of the PD01A immunotherapeutic. These
studies were registered at EudraCT (2011-002650-31, 2013-001774-20,
2014-002489-54 and 2015-004854-16).

*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 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.

*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.

For further information, please visit www.affiris.com [2] and follow us on
LinkedIn [3] and Twitter [4].

*Contact AFFiRiS AG: *
Dr. Cornelia Kutzer
E cornelia.kutzer@affiris.com
W www.affiris.com [2]

*Media contact:*
MC Services AG
Julia Hofmann
P +49 89 210228 0
E affiris@mc-services.eu

*About SAIT:*
https://affiris.com/approach/#overview-of-sait [5]

*About neurodegenerative diseases:*
https://affiris.com/neurodegenerative-diseases [6]

2020-06-18 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Archive at www.dgap.de
1072857 2020-06-18

1: https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=redirect&url=48bf9d6b43f7b15e714f9454606d21b8&application_id=1072857&site_id=vwd&application_name=news
2: https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=redirect&url=e9da3551de7c28af95536941ff04ca2c&application_id=1072857&site_id=vwd&application_name=news
3: https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=redirect&url=1c2158f5b2f3b33d6475d7ef16050db1&application_id=1072857&site_id=vwd&application_name=news
4: https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=redirect&url=43856ce28a657af4bb535ad43e8269df&application_id=1072857&site_id=vwd&application_name=news
5: https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=redirect&url=e0efda4fd8896c2d082dd0790be7b6b7&application_id=1072857&site_id=vwd&application_name=news
6: https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=redirect&url=38937a20df116b34afc6d892ef9afb43&application_id=1072857&site_id=vwd&application_name=news

(END) Dow Jones Newswires

June 18, 2020 03:05 ET ( 07:05 GMT)

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