Oxurion NV
Business Update - Q1 2019
Significant
Progress with Novel Clinical Diabetic Eye Disease Portfolio
Enrollment of
THR-317 Phase 2 Combination Study & THR-149 Phase 1 Study
Completed Ahead of Schedule
First Clinical
Readout Expected by Q3 2019
Total Cash &
Investments at €76.2 million on 31 March 2019
Highlights
-
Patient enrollment completed in April 2019 of
a Phase 2 trial evaluating the efficacy and safety of intravitreal
THR-317 (anti-PlGF) administered in combination with ranibizumab
(anti-VEGF) for the treatment of diabetic macular edema (DME)
-
Patient enrollment completed in April 2019 of a
Phase 1 dose escalation safety study evaluating THR-149 for the
treatment of DME
-
Results from THR-317 and THR-149 clinical
studies are expected by Q3 2019
-
Two further clinical read-outs expected before
end of 2019
-
Oxurion had €76.2 million in cash &
investments at the end of March 2019. This compares to €85.1
million at the end of December 2018.
Leuven, Belgium, May 8, 2019 - Oxurion NV
(Euronext Brussels: OXUR), a biopharmaceutical company developing
innovative treatments to preserve vision in patients with diabetic
eye disease, today issues a business update and a financial update
for the three-months ending March 31, 2019.
Oxurion is developing a
competitive pipeline of disease modifying drug candidates for
diabetic eye disease, particularly DME.
The Oxurion clinical development
pipeline consists of novel products with different modes of action,
which, together potentially give the Company access to a
significant share of the diabetic eye disease market. Oxurion's
clinical pipeline comprises of:
-
a human placental growth factor (PlGF)
neutralizing monoclonal antibody (THR-317)
which is in a Phase 2 study evaluating the efficacy and safety of
intravitreal THR-317 when administered in combination with
ranibizumab (Lucentis®), for the
treatment of DME. Recruitment of this study is completed, and
results are expected in early Q3 2019.
In addition, THR-317 is being
evaluated in a Phase 2 study for the treatment of Idiopathic
Macular Telangiectasia Type 1 (MacTel 1), a rare disease that
affects the macula and can lead to vision loss. First data from
this study are expected towards the end of 2019.
-
a potent plasma kallikrein inhibitor (THR-149) is in a Phase 1 multicenter, dose escalation
study for the treatment of DME. Recruitment of this study has
recently completed with results anticipated by early Q3
2019.
-
a small molecule pan-RGD integrin antagonist
(THR-687) being developed to treat a broad
range of patients with diabetic eye disease. THR-687 entered the
clinic in September 2018. Results from the on-going Phase 1 study
are expected towards the end of 2019.
Patrik De
Haes, MD, CEO of Oxurion nv, commented: "We are making excellent progress with our competitive
pipeline of disease-modifying drug candidates for diabetic eye
disease, the leading cause of blindness in people of working
age. We have completed recruitment ahead of schedule of
our Phase 2 study evaluating the efficacy and safety of
intravitreal THR-317 when administered in combination with
ranibizumab (Lucentis®), for the
treatment of DME. We have also completed recruitment of our Phase I
study with THR-149. Results from these studies are expected by Q3
2019. Later in the year we plan to announce the results from a
Phase I study with THR-687 and a Phase 2 study with THR-317 in
patients with MacTel1. We are confident that 2019 will be a
milestone year for Oxurion as we continue to advance our clinical
pipeline of novel disease-modifying therapies and remain confident
in their potential to preserve the vision of patients with diabetic
eye disease."
Diabetic Eye
Disease - A Significant and Growing area off medical need
Diabetes is a major global
healthcare problem with an estimated 425 million adults living with
diabetes worldwide today. This number is expected to increase to
over 625 million by 2045, according to the International Diabetes
Federation.
Diabetic eye disease is caused by
hyperglycemia (high blood glucose levels) associated with diabetes.
If left unchecked hyperglycemia causes damage to the capillaries
supplying blood and hence oxygen to the retina, the structure at
the back of the eye responsible for vison.
Diabetic retinopathy (DR) is a
serious, sight-threatening disease and the leading cause of vision
loss among working-age adults. DR progresses from mild,
non-proliferative to more severe or even proliferative stages.
It is estimated that there are 150 million diabetics with DR
of which 50 million have vision threatening disease.
Diabetic macular edema (DME) is a
severe complication of DR. DME is an accumulation of fluid in the
macula - the part of the retina that controls detailed vision - due
to leaking blood vessels. DME represents an area of major unmet
medical need. The current standard of care, anti-VEGFs, have shown
to deliver sub-optimal results, with more than 50% of patients
having an unsatisfactory early visual response with anti-VEGF
therapy, and many of cases failing to achieve a clinically
meaningful visual improvement over time.
Oxurion Clinical
and Pre-clinical Development Update
THR-317 - a Humanized mAb Against
Human PlGF for the treatment of DME
THR-317 (anti-PlGF) is a
recombinant humanized monoclonal antibody directed against the
receptor-binding site of human placental growth factor (PlGF) being
developed for the treatment of DME. In pre-clinical models,
anti-PlGF has been shown, in addition to anti-angiogenic and
anti-edema properties, to be anti-inflammatory.
Phase 2 Clinical
study evaluating THR-317 in combination with ranibizumab (Lucentis®), an
anti-VEGF
In April 2019, enrollment was
completed, ahead of schedule, for the Phase 2 study evaluating the
efficacy and safety of intravitreal THR-317 administered in
combination with ranibizumab (Lucentis®) a VEGF
inhibitor, for the treatment of DME.
Initial results from this Phase 2 clinical study are anticipated in
early Q3 2019. Results from this trial will provide the clinical
data needed to plan the next stages of THR-317's clinical
development.
Simultaneously inhibiting VEGF
(ranibizumab) and PlGF (THR-317) could deliver better efficacy than
either treatment alone. Non-clinical experiments indicate that
anti-PlGF in the presence of an anti-VEGF antibody has an additive
effect inhibiting the growth of new blood vessels (Van de
Veire et al.,2010), a disease hallmark of
DR.
Phase 2 clinical study evaluating
THR-317 for treatment of MacTel1
In September 2018, Oxurion started
a Phase 2 multi-center study evaluating the efficacy and safety of
intravitreal THR-317 for the treatment of Macular Telangiectasia
Type 1 (MacTel 1). MacTel 1 is a rare disease that affects the
macula and can lead to vision loss. There is currently no effective
treatment for MacTel 1.
This Phase 2 study plans to enroll
10 patients with macular edema caused by MacTel 1, who will each
receive three 8mg intravitreal THR-317 injections over a period of
2 months. Efficacy and safety of the therapy will be assessed via
functional and anatomic endpoints.
Initial results from this clinical
study are anticipated towards the end of 2019.
THR-149 - a
plasma kallikrein inhibitor for treatment of DME
Phase 1 study
evaluating THR-149, a Potent Plasma Kallikrein inhibitor, for the
treatment of DME
THR-149 is a novel plasma
kallikrein inhibitor, generated by using Bicycle Therapeutics'
Bicycles® technology platform, that is being developed for the
treatment of DME.
THR-149 acts through inhibition of
the Plasma Kallikrein-Kinin (PKaI-Kinin) system, which is
considered a validated target for DME.
Preclinical studies involving
THR-149 were published in The Journal of Medicinal
Chemistry in March 2018 and presented by Oxurion's senior
scientist Dr Tine Van Bergen at the Annual Meeting of the European
Association for the Study of Diabetes Eye Complications Study Group
(EASDec). The data demonstrate the potency and efficacy of bicyclic
peptide inhibitors of PKal, such as THR-149, via a VEGF-independent
pathway.
In May 2018, Oxurion initiated a
Phase 1 clinical study evaluating the safety of a single
intravitreal injection of escalating dose levels of THR-149 in
patients with DME.
Oxurion announced in April 2019 that all patients had been enrolled
in the clinical study, with initial results anticipated by early
Q3.
THR-687 - an
integrin antagonist for treatment of DME
Phase 1 study
evaluating THR-687, a novel pan-RGD integrin antagonist for the
treatment of DME
Oxurion is developing THR-687, a
novel pan-RGD integrin antagonist, to preserve vision of a broad
range of patients with diabetic eye disease. This wide-ranging
potential is based on the hypothesis that integrin inhibition can
address many of the processes that result in the pathological
angiogenesis and vascular leakage that cause diabetic eye
disease.
Oxurion is initially targeting
THR-687 for DME. In September 2018, THR-687 initiated a Phase 1
multicenter, dose escalation study evaluating the safety of a
single intravitreal injection of THR-687 for the treatment of
patients with DME. A maximum of 15 patients will be enrolled, with
initial results anticipated by the end of 2019.
Financial
Update
Oxurion had €76.2 million in cash
and investments at the end of March 2019. This compares with
€85.1 million as of the end of December 2018.
END
For further
information please contact:
Oxurion
NV
Wouter Piepers
Global Head of Investor Relations & Corp Coms
+32 16 75 13 10 / +32 478 33 56 32
wouter.piepers@oxurion.com
|
EU - Citigate Dewe Rogerson
David Dible / Sylvie Berrebi
+44 20 7638 9571
oxurion@citigatedewerogerson.com |
US - LifeSci Public Relations
Alison Chen
+1 646 876 4932
achen@lifescipublicrelations.com
|
About Oxurion
Oxurion (Euronext Brussels: OXUR)
is a biopharmaceutical company currently developing a competitive
pipeline of disease-modifying drug candidates for diabetic eye
disease, a leading cause of blindness in people of working age
worldwide.
Oxurion's most advanced drug
candidate is THR-317, a PlGF inhibitor for the treatment of
diabetic macular edema (DME), which is currently in a Phase 2 study
in combination with Lucentis®. THR-317 is
also being evaluated in a Phase 2 study for the treatment of
Idiopathic Macular Telangiectasia Type 1 (MacTel 1), a rare retinal
disease that affects the macula and can lead to vision loss.
Oxurion has two further pipeline
candidates, THR-149, a plasma kallikrein inhibitor being developed
for the treatment of DME; and THR-687, a pan-RGD integrin
antagonist in development for the treatment of diabetic retinopathy
and DME. Both THR-149 and THR-687 are in Phase 1 clinical
studies.
Oxurion is headquartered in Leuven, Belgium, and
is listed on the Euronext Brussels exchange under the symbol
OXUR.
More information is available at
www.oxurion.com.
Important information about forward-looking
statements
Certain
statements in this press release may be considered
"forward-looking". Such forward-looking statements are based on
current expectations, and, accordingly, entail and are influenced
by various risks and uncertainties. The Company therefore cannot
provide any assurance that such forward-looking statements will
materialize and does not assume an obligation to update or revise
any forward-looking statement, whether as a result of new
information, future events or any other reason. Additional
information concerning risks and uncertainties affecting the
business and other factors that could cause actual results to
differ materially from any forward-looking statement is contained
in the Company's Annual Report. This press
release does not constitute an offer or invitation for the sale or
purchase of securities or assets of Oxurion in any
jurisdiction. No securities of Oxurion may be offered or sold
within the United States without registration under the U.S.
Securities Act of 1933, as amended, or in compliance with an
exemption therefrom, and in accordance with any applicable U.S.
state securities laws.
This
announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Oxurion NV via Globenewswire
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