Probiodrug
initiates Phase 2b core program of PQ912 and details further
strategy
Company moves
seamlessly from finalization of the SAPHIR Phase 2a to next
clinical stage
Probiodrug takes a double-pronged strategy -
starts operational preparation of clinical studies with PQ912 while
in parallel continuing the interaction with potential pharma
partners to achieve the best value creating solution
HALLE (SAALE),
Germany, 16 October 2017 - Probiodrug AG (Euronext
Amsterdam: PBD), a biopharmaceutical company developing novel
therapeutic solutions to treat Alzheimer's disease (AD), today
announced that after finalization of the SAPHIR Clinical Study
Report at 25th of September
2017, it has signed a Letter of Agreement with the Contract
Research Organization Julius Clinical, Zeist, NL, in order to
continue the excellent collaboration of the SAPHIR study into the
next development step. With this agreement the preparation of the
Phase 2b core program starts which is planned to comprise of two
complementary clinical Proof of Concept studies in Europe and the
US.
A first Phase 2b study is intended
to investigate the safety and efficacy of the optimal dose range of
PQ912 in early AD patients. This trial will build on the excellent
and efficient infrastructure which was established for the Phase 2a
SAPHIR study. Moreover, it is based on the valuable results of the
SAPHIR study and has been designed with the guidance of
international KOL`s in the Alzheimer's field. Philip Scheltens MD
PhD, Director of the Alzheimer Center VU University Medical Center
Amsterdam will once again serve as Principle Investigator and
Chairperson for this study, which is to be conducted in the EU.
A second complementary study is
currently in the planning phase and is intended to be carried out
in the USA and will also be chaired by a highly renowned Principle
Investigator.
The envisioned Phase 2b core
program will address and answer a number of important questions in
order to proceed to full Phase 3 development. Key components of the
tailored program are dose-dependency of tolerability and efficacy
after longer treatment duration. In parallel with the preparations
for the Phase 2b program, Probiodrug will continue its discussions
with potential pharma partners regarding the SAPHIR results and
avenues for collaboration.
Inge Lues, Chief
Development Officer at Probiodrug commented: "The positive
SAPHIR study results created an accelerating positive momentum
toward starting a clinical Phase 2b program for PQ912. The Phase 2a
results are tremendously useful in enabling the design of a
tailored program comprising two clinical studies, one planned in
Europe and the second in the USA. We expect that this program will
answer important questions enabling us to progress PQ912 into the
confirmatory Phase 3 program."
Konrad Glund,
Chief Executive Officer at Probiodrug commented: ''In parallel
to driving the Phase 2b initiative ourselves, we are continuing
pharma interactions. The increasing evidence for targeting toxic
Abeta oligomers as a key culprit of the AD pathology, in which
pGlu-Abeta seems to play a significant role, is providing sound
support for our efforts. We are confident that this double-pronged
strategy will efficiently expedite and safeguard the advanced
development of PQ912."
###
For more
information, please contact:
Probiodrug
Dr Konrad Glund, CEO
Email: contact@probiodrug.de
Hume
Brophy
Conor Griffin, Alexander Protsenko, Jonothan Blackbourn
Tel: +44 (0) 20 7862 6381
Email: probiodrug@humebrophy.com
The Trout
Group
Tricia Truehart, Kelly Mueller
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
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 Alzheimer's disease
initiation and progression. The development approaches are
targeting a key neuro/synaptotoxic component of the pathology,
pyroglutamate-Abeta (pGlu-Abeta, N3pG) as a therapeutic
strategy.
Probiodrug's lead product
candidate, PQ912, is a highly specific and potent inhibitor of
Glutaminyl Cyclase (QC), which has shown therapeutic effects in AD
animal models. A Phase 1 study with healthy young and elderly
volunteers revealed a dose dependent exposure and showed good
safety and tolerability up to the highest dose showing >90%
target occupancy in the spinal fluid. In June 2017 Probiodrug
announced top-line data of the Phase 2a SAPHIR trial of its lead
candidate (Probiodrug announces encouraging results of the Phase 2a
SAPHIR Study ). The positive effects seen on secondary exploratory
efficacy markers are strongly supporting (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.
Complementary to the small
molecule PQ912 inhibiting the formation of the synaptotoxic agent
pGlu-Abeta, the company is developing PBD-C06, an
anti-pGlu-Abeta-specific monoclonal antibody.The Company 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. 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 aims to become a
leading company in the development of AD treatments and to thereby
provide a better life for Alzheimer's disease patients.
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.