Probiodrug
announces publication of initial PQ912 clinical data demonstrating
inhibition of glutaminyl cyclase
PQ912
is currently in Phase 2a studies in Alzheimer's disease
patients
HALLE/SAALE, Germany, 15 December 2015
- Probiodrug AG (Euronext Amsterdam: PBD), a biopharmaceutical
company developing novel therapeutic solutions to treat Alzheimer's
disease (AD), today announced that data from an extensive
phase 1 study with PQ912, its lead glutaminyl cyclase (QC)
inhibitor for the treatment of AD, have been published in Alzheimer's & Dementia: Translational Research &
Clinical Interventions, Volume 1, Issue 3, Pages 182-195. PQ912
is a first-in-class competitive inhibitor of glutaminyl cyclase,
essential for the formation of pyroglutamate-Amyloid-beta
(pGlu-Abeta). PGlu-Abeta seeds Abeta oligomers which, due to their
hypertoxicity, are regarded as the key culprits behind AD.
In the published data, over 200
young and elderly healthy volunteers were included in a single-and
multiple-ascending dose design. PQ912 was found to be safe and well
tolerated; the maximum tolerated dose was not reached. The study
also evaluated pharmacokinetic parameters of the compound as well
as the extent of QC inhibition in the cerebral spinal fluid (CSF),
which is a measure for QC-inhibition in the brain. Based on the
data obtained in CSF, the dose dependent target inhibition could be
reliably determined and was used for dose selection in the current
phase 2a trial. The study was conducted with Covance in Switzerland
and the UK.
Dr Inge Lues,
Chief Development Officer at Probiodrug and first author of the
paper, said: "This is ground-breaking data as for the first
time a compound targeting glutaminyl cyclase (QC) enzyme inhibition
has been assessed in man for the inhibition of
pyroglutamate-amyloid-beta (pGlu-Abeta) formation and thus
potentially the treatment of AD.
"The primary objective of our
ongoing phase 2a study (SAPHIR) is to evaluate the safety of PQ912
in the AD patient population. Exploratory read-outs are also
included to investigate the hypotheses that inhibition of QC
interferes with AD pathology. Beside sensitive cognitive measures
to capture acute cognitive improvement, we are also measuring by
means of EEG and functional MRI any effects on synaptic plasticity
and neuronal connectivity, the physiological basis of memory and
learning. In addition, we will introduce a set of biomarkers
closely related to the concept, Abeta Oligomer- and pE-Abeta levels
in CSF to learn about their potential as AD biomarkers."
Dr Konrad Glund,
CEO of Probiodrug and co-author, added: "The publication of the
phase 1 results in a peer reviewed journal marks an important
milestone for Probiodrug. The company has progressed the project
from the discovery of QC as the enzyme responsible for modifying
truncated Abeta into pGlu-Abeta to the current stage. The resulting
data provide the basis for testing the attractive hypothesis of
inhibiting QC as a treatment for AD in patients, which we are
currently evaluating in our phase 2a study.
"This concept of preventing the
formation of pGlu-Abeta via QC inhibition as a treatment for AD
addresses exclusively toxic Abeta species, and is unique and
differentiated to any other Abeta focused therapeutic concept."
The article "A phase 1 study to evaluate the
safety and pharmacokinetics of PQ912, a glutaminyl cyclase
inhibitor, in healthy subjects; Lues, Inge et al, Alzheimer's & Dementia: Translational Research &
Clinical Interventions [Volume 1, Issue 3, Pages 182-195], can
be found here: http://dx.doi.org/10.1016/j.trci.2015.08.002.
###
For more
information, please contact:
Probiodrug
Dr Konrad Glund, CEO
Email: contact@probiodrug.de
Hume
Brophy
Supriya Mathur, Eva Haas, Alexia Faure
Tel: +44 (0) 203 440 5657
Email: probiodrug@humebrophy.com
The Trout
Group
Tricia Truehart
Tel: +1 (646) 378-2953
Email: ttruehart@troutgroup.com
Notes to
Editors:
About Probiodrug
AG
Headquartered in Halle, 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.
Founded in 1997, 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. Its core capabilities are based on
its long-standing expertise in the elucidation of the structure and
function of enzymes involved in the modification of proteins and
peptides, which play a central role in pathological conditions.
Today Probiodrug's aim is to
become a leading company in the development of Alzheimer's disease
treatments and to thereby provide a better life for Alzheimer's
disease patients. It has identified a new therapeutic concept
linked to disease initiation and progression. The development
approaches are targeting pyroglutamate-Abeta (pGlu-Abeta) as a
therapeutic strategy to fight Alzheimer's disease. The Company has
medical use and composition of matter patents related to the
inhibition of Glutaminyl Cyclase (QC) and anti-pGlu-Abeta- specific
monoclonal antibodies, providing it, in the Company's view, with a
leading position in this field of research.
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. Because
Alzheimer's disease cannot be cured and is degenerative, the
affected patients must increasingly rely on others for assistance.
Today, 44 million people worldwide currently live with the
condition and this number is expected to almost double by 2030 and
to more than triple by 2050 to over 132 million. Alzheimer's also
has an estimated, global societal cost of over $600 billion (World
Alzheimer Report 2014).
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.