Probiodrug reports
Third Quarter 2016 Business Update
HALLE/SAALE,
Germany, 10 November 2016 - Probiodrug AG (Euronext Amsterdam:
PBD), a biopharmaceutical company developing novel therapeutic
solutions to treat Alzheimer's disease (AD), today announces its
third quarter business update for the period ending 30 September
2016, in the form of an interim management report.
The interim management report for
the third quarter 2016 is available for download on the company
website
(http://www.probiodrug.de/investors/reports-and-presentations/).
OPERATIONAL
HIGHLIGHTS
-
Probiodrug announced first data of a
preclinical combination therapy with the Glutaminyl Cyclase (QC)
inhibitor PQ912 and the pGlu-Abeta specific antibody PBD-C06, which
showed clear additive effects in reducing pGlu-Abeta as well as
overall Abeta in an Alzheimer-mouse model
-
Promising new findings for the
Glutaminyl Cyclase inhibitor PQ912 in an inflammation animal
model presented
-
Changes to the Supervisory Board and
Executive Management announced
-
Expenditures and corresponding cash
position in line with management expectations
-
As of 30 September 2016 (excluding the
proceeds of EUR 14.9 million from the capital raise of October),
Probiodrug held EUR 11.57 million in cash and cash
equivalents
POST PERIOD HIGHLIGHTS
Commenting on the third quarter,
Dr Konrad Glund, Chief Executive Officer of Probiodrug,
said:
"In the third quarter 2016 we have
achieved significant progress, both in the development of our
programs as well as of the company. In a combination therapy study
with PQ912 and PBD-C06, we showed clear additive effects in
reducing pGlu-Abeta as well as total Abeta in an Alzheimer-mouse
model. Our results are very exciting as they indicate the potential
of a combination therapy by either increasing the effect size on
lowering toxic pGlu-Abeta and total Abeta as shown here, or
potentially by lowering a single agent's dose.
"Furthermore, we see the
successful placement of 10% of the then outstanding shares at the
beginning of October as a further validation of the potential of
our approach to fight Alzheimer's disease. We are glad to welcome
further top tier investors from Europe and the US as shareholders
of our company and would like to thank our existing and new
investors for their trust and commitment."
OPERATIONAL
REVIEW
Pipeline
update
Probiodrug's development approach targets pyroglutamate-Abeta
(pGlu-Abeta, also called N3pG Abeta) as a therapeutic strategy to
fight Alzheimer's disease. This modified Abeta is considered to be
linked with disease initiation and progression by seeding the
formation of soluble neurotoxic amyloid oligomers. Probiodrug is
developing proprietary product candidates to target toxic
pGlu-Abeta via two modes of action: by (i) inhibiting the
production of pGlu-Abeta; and (ii) clearing existing pGlu-Abeta
from the brain.
Probiodrug's innovative approach
is based on the development of specific inhibitors for the enzyme
Glutaminyl Cyclase (QC), which is instrumental in the creation of
pGlu-Abeta. In addition, the company is developing a monoclonal
antibody targeting pGlu-Abeta to enhance its clearance.
To date, Probiodrug's pipeline
consists of two small molecule inhibitors of the QC-enzyme, PQ912
and PQ1565, and a monoclonal antibody, PBD-C06, targeting
pGlu-Abeta.
PQ912
In 2015, Probiodrug initiated a Phase 2a study, the "SAPHIR" study,
of its lead product candidate PQ912. In a preceding Phase 1 study
with healthy young and elderly volunteers, PQ912 was shown to be
safe and well tolerated and revealed high QC-inhibition.
PQ912 has been evaluated in rats
and dogs in 4 weeks, 3 months and 6/9 months studies. In the
chronic toxicology studies no new findings were observed and the
minimal to slight, non-adverse changes seen in both the 4-week and
the 13-week studies were without any aggravation by the prolonged
treatment. The conclusions from these peer-reviewed results of the
long term toxicology studies are viewed as the regulatory
prerequisite for longer treatment clinical studies in AD
patients.
PQ912 is the first QC-inhibitor
being tested in patients. The Phase 2a study is a randomized,
double-blind multi-center study which plans to enrol a total of 110
patients with early stage Alzheimer's disease. The study is led by
internationally renowned experts in AD in six European countries at
about 18 sites, with the Alzheimer Center, VU Medical Center
(VUmc), Amsterdam being the lead center. The primary endpoint of
the trial is the safety and tolerability of PQ912 compared with
placebo over a three-month treatment period. Additionally, a set of
exploratory read-outs comprising of cognitive tests, functional
assessments by EEG as well as functional MRI and new molecular
biomarkers in CSF which will be used to evaluate the compound's
effect on the pathology of the disease. Patient enrolment started
in March 2015.
SAPHIR is in full swing. To
respond to several challenges such as high competition in getting
access to treatment naïve patients, we have taken various measures,
in particular adding more sites in various countries while keeping
quality at high level. Additional sites are activated, all are
highly motivated and enrolling. The full picture of all results is
expected to be available Q1 / Q2 2017.
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.
PQ1565
PQ1565 is a QC-inhibitor, currently in preclinical stage. The
product candidate has shown attractive drug-like properties in
preclinical studies. The GMP process for this molecule is being
implemented.
The next development steps are in
preparation and respective decisions would be made in connection
with the readout of the SAPHIR trial.
Operational
Update
Combination
therapy with Glutaminyl Cyclase (QC) inhibitor PQ912 and pGlu-Abeta
specific antibody PBD-C06
A clear additive effect on lowering pGlu-Abeta
(pyroglutamate-Amyloid-beta) as well as total Abeta was observed
with a double-pronged approach of targeting toxic pGlu-Abeta by
combining the Glutaminyl Cyclase-inhibitor PQ912 to block
pGlu-Abeta formation and the mouse version of the pGlu-Abeta
specific antibody, PBD-C06, to increase clearance in an AD animal
model. Data were generated in collaboration with Cynthia Lemere of
the Brigham and Women's Hospital, Harvard Medical School, USA, and
QPS, Graz, Austria.
Promising
new findings for the Glutaminyl Cyclase (QC)
inhibitor PQ912 in an inflammation animal model
The effect of the QC inhibitor PQ912 was investigated in a mouse
model of inflammation (thioglycollate induced peritonitis) with a
special focus on its effect on cell infiltration and release of
pro-resolving lipid mediators. The effects seen with PQ912 on
recruitment of macrophages and eosinophils, and levels of
chemokines and lipid mediators, makes QC inhibition attractive for
further evaluation as potential anti-inflammatory drug and/or
resolution promoting agent. Data were generated in collaboration
with Ambiotis SAS (Toulouse, France) and were presented at the
Summer Frontiers Symposium 2016 in Nijmegen, The Netherlands, and
at the 6th European Workshop on Lipid Mediators, in Frankfurt,
Germany.
CORPORATE
REVIEW
Changes to the
Supervisory Board and Executive Management announced
Probiodrug announced changes to the Supervisory Board and Executive
Management. Olivier Litzka, partner at Edmond de Rothschild
Investment Partners (EdRIP) and member of the Supervisory Board
since October 2009, stepped down in September 2016 as part of a
natural transition. Mark Booth, Chief Business Officer, left the
company for personal reasons in August 2016 and his
responsibilities have been taken over by Dr Konrad Glund, CEO.
Financials
In third quarter of 2016 the research and development expenses were
with TEUR 1,776 below the corresponding numbers of 2015 with TEUR
2,416, reflecting mainly shifts and not real reductions. In line
with the business planning the general and administrative expenses
further decreased to TEUR 588 vs. TEUR 713 in the third quarter of
2015, reflecting the implementation of the post listing
requirements mainly accomplished in 2015. Correspondingly, the
resulting comprehensive loss of the reporting period was TEUR
2,383, below the comprehensive loss of the third quarter of 2015
(TEUR 3,148).
The comprehensive loss for the
nine month period ending 30 September 2016 was TEUR 8,427, compared
to TEUR 9,377 for the corresponding period in 2015. Thereof TEUR
6,487 were research and development expenses in comparison to TEUR
6,927 in the nine month period 2015. TEUR 1,912 were general and
administrate expenses in comparison to TEUR 2,585 for the nine
months 2015.
All numbers are in line with
management expectations.
Excluding the proceeds from the
capital raise of October of EUR 14.9 million, Probiodrug held EUR
11.57 million in cash and cash equivalents as of 30 September
2016.
POST PERIOD
UPDATE
Placement of new
shares
Probiodrug announced a EUR 14.9 million placement of new shares on
6 October 2016 via an accelerated bookbuild. As a result Probiodrug
increased its share capital by EUR 744,248, from EUR 7,442,487 to
EUR 8,186,735, by issuing 744,248 new shares with a notional par
value of EUR 1.00 per share. The order book was well covered based
on strong demand from European and US investors. The new shares
have been placed with selected qualified institutional investors at
a price of EUR 20.00 per share. The issued shares represented
approximately 10% of the company's then issued share capital. The
net proceeds from the transaction will be used primarily to support
preparations of further clinical development of the lead product
PQ912 beyond the ongoing Phase 2a (SAPHIR) trial, support further
development of PBD-C06 and PQ1565 and exploration of other
mechanism-related indications, strengthen the financial position of
the Company and support exploration of business opportunities.
Kempen & Co acted as Global
Coordinator and together with Bank am Bellevue and RBC Capital
Markets as Joint Bookrunners in the offering.
###
For more
information please contact:
Probiodrug
Dr Konrad Glund, CEO
Email: contact@probiodrug.de
Hume
Brophy
Mary Clark, Supriya Mathur, Eva Haas
Tel: +44 (0) 207 862 6475
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.
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
population's age. Dementia also has a huge economic impact.
Alzheimer's also 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.