Probiodrug
announces completion of recruitment for the SAPHIR Phase 2a study
of Glutaminyl Cyclase Inhibitor PQ912 in early Alzheimer's disease
patients
HALLE (SAALE),
Germany, 09 January 2017 - Probiodrug AG ("Probiodrug",
Euronext: PBD), a biopharmaceutical company developing novel
therapeutic solutions to treat Alzheimer's disease (AD), announces
that recruitment for the Phase 2a SAPHIR study has been completed
in mid-December 2016. A total of 120 patients have been randomised,
surpassing the 110 patients planned in the study protocol.
The SAPHIR study is a randomized,
double blind study comparing PQ912 to placebo in treatment naïve
patients with early AD. PQ912 targets inhibition of the Glutaminyl
Cyclase (QC) enzyme which reduces production of highly neurotoxic
pGlu-Abeta and related oligomers implicated in AD. PQ912 has been
extensively investigated in a Phase 1 SAD/MAD study showing good
tolerability and a dose dependent QC-inhibition in the spinal
fluid.
The primary objective of the
SAPHIR study is to investigate the safety of PQ912 in the target
population and the secondary objective is to assess the
pharmacodynamics profile through various readouts.
In this study Mini-Mental State
Examination (MMSE) and the Cogstate neuro-psychological tests are
monitored blindly every 30 patients to ensure consistency and
reliability of ratings. First blinded results at baseline show that
the mean MMSE scores from the 120 randomised patients is 25.3, the
mean age is 73 years and gender distribution is 64 female and 56
male. Current results indicate a low variability and therefore the
high quality of the assessments being used.
Full unblinded results of the
SAPHIR study are expected in the second quarter of 2017.
###
For more
information, please contact:
Probiodrug
Dr Konrad Glund, CEO
Email: contact@probiodrug.de
Hume
Brophy
Conor Griffin, Alexia Faure, Alex Protsenko
Tel: +44 (0) 20 7862 6381
Email: probiodrug@humebrophy.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.
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.
Probiodrug's lead product
candidate, PQ912, is a highly specific and potent inhibitor of
Glutaminyl Cyclase (QC), which has shown therapeutic effects in
Alzheimer's animal models. PQ912 is currently in a Phase 2a study,
the SAPHIR trial. In a preceding Phase 1 study with healthy young
and elderly volunteers, PQ912 has shown to be safe and well
tolerated and also revealed high QC-inhibition.
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, 47 million people live with dementia worldwide, and this
number is projected to treble to more than 131 million by 2050, as
populations age. 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.