Probiodrug
positioning its pGlu-Abeta Antibody in the field of Abeta
antibodies
Probiodrug
co-authored a review paper entitled
"Passive Abeta Immunotherapy: Current
Achievements and Future Perspectives "
HALLE (SAALE), Germany, 08 May
2018 Probiodrug AG (Euronext Amsterdam: PBD), a clinical stage
biopharmaceutical company developing novel therapeutic solutions to
treat Alzheimer's disease (AD), today announced that results from
its preclinical candidate antibody PBD-06 were reviewed :
Schilling, S., Rahfeld, J.-U., Lues, I. and Lemere, C.A. in
Molecules and can be found here:
http://www.mdpi.com/1420-3049/23/5/1068/pdf
The review article is authored by
researchers from the Fraunhofer-Institute for Cell
Therapy and Immunology, Germany, the Ann Romney Center for
Neurologic Diseases, Brigham and Women's Hospital and Harvard
Medical School, USA and Probiodrug AG, Germany. It is part of a
special issue dedicated to the 25th anniversary
of the amyloid cascade hypothesis, the leading hypothesis of the
pathology of the Alzheimer's disease (AD). The review
highlights the current development status of monoclonal antibodies
in advanced clinical development for the treatment of AD. A special
emphasis is put on current limitations of immunotherapy of AD
and recent strategies to overcome these issues by tailoring the
specificity and effector function of the antibodies. Probiodrug's
strategy to target pGlu-Abeta, a highly aggregatable and neurotoxic
form of amyloid peptide specific for AD, is comprehensively
reviewed as well as the status of preclinical pGlu-Abeta antibody
developments. PBD-C06 is PBD's humanized and deimmunized
anti-pGlu-Abeta monoclonal antibody currently in CMC development.
The molecule was selected based on an optimal pharmacological
profile.
Dr. Stephan
Schilling from the Fraunhofer Institute for Cell Therapy and
Immunology IZI comments: "The review provides an overview on
current strategies to improve immunotherapeutics for the treatment
of AD. Among those, especially the targeting of posttranslationally
modified amyloid peptides such as pGlu-Abeta offers several
advantages for a treatment with low risk of side effects."
Dr. Schilling is a group leader at Fraunhofer IZI and serves
together with Dr. Hutter-Paier (QPS Austria) as a guest editor of
the special issue.
Dr. Inge Lues,
Chief Development Officer of Probiodrug added: "The review
highlights the differentiating factors of anti-pGlu3-Abeta
immunontherapy over other monoclonal antibodies, providing a
comprehensive overview on the mode of action of our development
candidate PBD-C06."
Probiodrug is progressing two
complementary strategies for tackling pGlu-Abeta with two
candidates in development: PQ912, a small molecule inhibitor of
Glutaminyl Cyclase, now in Phase 2, and PBD-C06, a
pGlu-Abeta-specific monoclonal antibody in preclinical stage.
###
For more information, please
contact:
Probiodrug
Dr. Ulrich Dauer, CEO
Email: contact@probiodrug.de
Optimum Strategic
Communications
Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 (0) 203 714 1787
Email: probiodrug@optimumcomms.com
The Trout Group
Tricia Truehart
Tel: +1 (646) 378-2953
Email: ttruehart@troutgroup.com
MC Services AG
Anne Hennecke, Caroline Bergmann
Tel: +49 (0) 211 529 252 20
Email: probiodrug@mc-services.eu
Notes to Editors:
About Probiodrug AG
Headquartered in Halle (Saale), Germany, Probiodrug AG (Euronext
Amsterdam: PBD) is a biopharmaceutical company focused on the
development of new therapeutic products for the treatment of
Alzheimer's disease (AD). Probiodrug has identified a new
therapeutic concept linked to disease initiation and progression.
The approaches are targeting a key neuro/synaptotoxic component of
the pathology, pyroglutamate-Abeta (pGlu-Abeta) as a therapeutic
strategy. Its lead product, PQ912, has successfully completed a
Phase 2a (SAPHIR) study. The company's pipeline also includes
PBD-C06, an anti-pGlu-Abeta-specific monoclonal antibody, in
preclinical development. Probiodrug has medical use and composition
of matter patents related to the inhibition of QC and
anti-pGlu-Abeta-specific monoclonal antibodies, and has, in the
Company's view, a leading position in this field of research.
Founded in 1997 by Hans-Ulrich
Demuth and Konrad Glund, the company successfully developed a novel
therapeutic concept for diabetes - the DP4 inhibitors - which
provided the basis for a novel class of antidiabetics - the
gliptins. Today, Probiodrug aims to become a leading company in the
development of AD treatments and to thereby provide a better life
for Alzheimer's disease patients.
About
PBD-C06
PBD-C06 is a monoclonal antibody, currently in preclinical stage.
PBD-C06 targets pGlu-Abeta, aiming to selectively clear the brain
of pGlu-Abeta while leaving non-toxic forms of Abeta untouched. PBD
C06 has been successfully humanized and also de-immunized to avoid
detection by the patient's endogenous immune system. For the first
time for an anti-pGlu-Abeta approach, PBD-C06 has not only shown
the ability to reduce Abeta/plaques but also to significantly
improve cognitive deficits in aged Alzheimer's mice. Moreover, no
evidence was found of increased microhemorrhages after treatment
with PBD-C06.
About
PQ912
Probiodrug's lead product candidate, PQ912, is a highly specific
and potent inhibitor of Glutaminyl Cyclase (QC), the enzyme
catalyzing the formation of synaptotoxic pGlu-Abeta. PQ912 has
shown therapeutic effects in AD animal models. A Phase-1 study
in healthy young and elderly volunteers revealed a dose
dependent exposure and showed good safety and tolerability up
to the highest dose with >90% target occupancy in the
spinal fluid. In June 2017, Probiodrug announced top-line data of
the Phase-2a SAPHIR trial of PQ912 and presented the study results
at CTAD 2017. The positive effects seen on secondary exploratory
efficacy markers strongly support (a) the hypothesis of pGlu-Abeta
being synaptotoxic and (b) the therapeutic concept pursued by
Probiodrug. The study revealed a positive benefit risk ratio of
PQ912 and provides important guidance how to move forward in the
development of PQ912 as a disease-modifying drug for AD.
Altogether, the results make the program highly attractive for
further development; the company has initiated the preparation of a
Phase 2b core program.
www.probiodrug.de
About Alzheimer's
disease
Alzheimer's disease is a neurological disorder, which is the most
common form of dementia, and ultimately leads to death. Today, 47
million people live with dementia worldwide, and this number is
projected to treble to more than 131 million by 2050, as the global
population ages. Dementia also has a huge economic impact.
Alzheimer's has an estimated, global societal cost of US$ 818
billion, and it will become a trillion dollar disease by 2018.
(World Alzheimer Report 2016).
Forward Looking Statements
Information set forth in this press release
contains forward-looking statements, which involve a number of
risks and uncertainties. The forward-looking statements contained
herein represent the judgment of Probiodrug AG as of the date of
this press release. Such forward-looking statements are neither
promises nor guarantees, but are subject to a variety of risks and
uncertainties, many of which are beyond our control, and which
could cause actual results to differ materially from those
contemplated in these forward-looking statements. We expressly
disclaim any obligation or undertaking to release publicly any
updates or revisions to any such statements to reflect any change
in our expectations or any change in events, conditions or
circumstances on which any such statement is based.