Probiodrug
publishes SAPHIR data in peer reviewed journal
SAPHIR trial data published in Alzheimer's Research &
Therapy
HALLE (SAALE),
Germany, 16 October 2018 - Probiodrug AG (Euronext
Amsterdam: PBD), a clinical stage biopharmaceutical company
developing novel therapeutic solutions to treat Alzheimer's disease
(AD), announced today that results from its SAPHIR trial were
published in one of the leading peer-reviewed medical journals,
Alzheimer's Research & Therapy.
The publication entitled:
"Safety, tolerability and efficacy of the
glutaminyl-cyclase inhibitor PQ912 in Alzheimer's disease: results
of a randomized, double-blind, placebo-controlled Phase 2a
Study," can be found here.
The publication summarizes and
highlights the results of the SAPHIR trial (Clinicaltrials.gov, NCT
02389413) which is the first clinical trial to investigate the
Glutaminylcyclase (QC) inhibitor PQ912 in patients with early AD.
The aim of the Study was to determine the maximal tolerated dose,
target occupancy and treatment related pharmacodynamic effects.
PQ912 is Probiodrug's lead product candidate and a first-in-class
QC inhibitor. The results further confirm Probiodrug's treatment
approach and strongly encourage the advancement into the next
development phase.
Prof. Dr. Philip Scheltens,
Principal Investigator of the SAPHIR study commented: "The
results of the SAPHIR trial are highly encouraging, and endorse the
potential of PQ912 as a novel disease modifying therapy. Results
need to be confirmed in a larger trial for which preparation are on
going. Alzheimer's impacts a huge population which is in dire need
of treatment options."
The article is authored by
researchers from VU University Medical Center, Amsterdam, The
Netherlands; University of Eastern Finland, Kuopio, Finland;
Technische Universität München, Munich, Germany; University of
Münster, Münster, Germany; Cogstate Ltd., Melbourne, Australia;
King's College London, UK; UMC Utrecht, The Netherlands; Brain
Research Center, Amsterdam, The Netherlands; Probiodrug AG, Halle,
Germany.
###
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
MC Services AG
Anne Hennecke, Susann Kutter
Tel: +49 (0) 211 529 252 27
Email: probiodrug@mc-services.eu
Notes to
Editors:
About Probiodrug AG
Headquartered in Halle (Saale), Germany, Probiodrug AG (Euronext
Amsterdam: PBD) is a clinical stage 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 development 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.
About
PQ912
PQ912, is a first in class, 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 resulting in >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. Results strongly support
(a) the hypothesis of pGlu-Abeta being synaptotoxic and (b) the
therapeutic concept pursued by Probiodrug. The study provides
important guidance how to move forward with 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, 50
million people live with dementia worldwide, and this number is
projected to treble to more than 152 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$ 1
trillion, and it will become 2 trillion dollar disease by 2030.
(World Alzheimer Report 2018).
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.