Oxurion NV Business Update - Q1 2020
Oxurion NV Business Update - Q1
2020
Progressing Clinical Development of Next
Generation Therapies for Diabetic Eye Disease – Beyond
anti-VEGF
Total Cash & Investments at €43.8
million as of March 31,
2020
Highlights
- Positive data from Phase 1 study evaluating THR-687 (Pan-RGD
integrin antagonist) for the treatment of Diabetic Macular Edema
(DME) announced in January 2020.
Preparations for planned Phase 2 study with THR-687 in DME
on-going. Study expected to start in H1 2021.
- Phase 2 study with THR-149 in DME is now expected to start H2
2020, or as soon as COVID-19 related safety considerations allow.
Preparations progressing as planned.
- At the end of March 2020, Oxurion had cash, cash equivalents
& investments of €43.8 million.
Leuven, Belgium, May 7, 2020 – 17.45 PM
CET – Oxurion NV (Euronext Brussels: OXUR), a
biopharmaceutical company engaged in the development of next
generation therapies to treat diabetic eye disease, today issues
its business and financial update for the three-months ending March
31, 2020.
Oxurion continues to progress the development of
its pipeline of innovative drug candidates for treating Diabetic
Macular Edema (DME). Diabetic eye disease, including DME, is a
significant global healthcare problem and the major cause of
blindness in adults of working-age.
Oxurion’s clinical development pipeline consists
of novel products with different, including non-VEGF, modes of
action, which potentially give the Company access to a significant
share of the large and fast-growing diabetic eye disease
market.
Oxurion’s clinical pipeline comprises of
- THR-149: a potent plasma kallikrein inhibitor
completed a Phase 1 multicenter, dose escalation study for the
treatment of DME in July 2019. Positive data showed that
THR-149 is well-tolerated and safe with no dose-limiting toxicities
or drug-related serious adverse events reported. The data also
showed promising efficacy results in relation to Best Corrected
Visual Acuity (BCVA) after a single injection and for up to 90 days
of follow up.
- THR-687: a small molecule pan-RGD integrin
antagonist is being developed to treat a broad range of patients
with diabetic eye disease. A Phase 1 study was completed in January
2020 and the data showed it to be well-tolerated and safe. The data
also showed promising efficacy results with rapid onset of action
and prolonged improvement in BCVA following a single
injection.
Patrik De Haes, M.D., CEO of
Oxurion, commented:
“The positive Phase 1 results that we announced
in January from the Phase 1 trial with THR-687 have strengthened
Oxurion’s position as a leader in developing safe and effective
next generation therapies for DME and diabetic eye disease.
Based on the preclinical and clinical data
to-date, THR-687, a small molecule pan-RGD integrin antagonist,
clearly has the potential to deliver improved clinical benefits to
a broader population of patients with diabetic eye disease than
currently approved anti-VEGF treatments.
We are preparing a Phase 2 study with THR-687
which is expected to start in H1 2021.
We have delayed the start of our planned Phase 2
study evaluating multiple doses of THR-149 in patients with DME due
to the current Covid-19 pandemic. We are continuing to prepare for
this important trial and expect the study to start as soon as
conditions allow us to proceed in an efficient manner, taking into
account the safety of everyone who will be involved.
Our current cash position of €43.8 million will
allow us to develop these exciting next generation therapies
designed to provide both patients and physicians with improved
treatment options for diabetic eye disease through mid-2021.”
Diabetic Eye Disease – Oxurion’s key focus
Diabetic eye disease is caused by the high blood
glucose levels (hyperglycemia) 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 eye disease includes Diabetic
Retinopathy (DR) and Diabetic Macular Edema (DME).
DR is the presence and characteristic evolution
of typical retinal microvascular lesions in an individual with
diabetes, leading to damage to the blood vessels in the retina. DR
is a chronic, progressive, sight-threatening, and life-altering
disease, and is the leading cause of vision loss in working-age
adults (20-65 years).
DR can be further classified by severity types,
non-proliferative diabetic retinopathy (NPDR) and proliferative
diabetic retinopathy (PDR).
DME, which is a consequence of DR, can occur at
any stage in the development of DR. DME is an accumulation of fluid
in the macula (central part of the retina) due to leaking blood
vessels, leading to swelling of the macular area due to the
increased permeability of the vessels.
More than one in three people living with
diabetes will develop some form of DR in their lifetime. Almost one
in three people living with DR have some vision-threatening form of
the disease such as DME and/or PDR.
DR and DME are a growing public health concern
due to the rapid growth in the number of people with diabetes
globally.
An estimated 37.8 million people have been
diagnosed with diabetes in the United States (US), European top
five countries (EU5) (France, Germany, Italy, Spain, and the United
Kingdom), and Japan. If the undiagnosed population is included, the
total number of persons with diabetes in these countries is
estimated to increase to 61.3 million people.
The prevalence of DME was estimated to be 2.8
million people in the US, EU5 and Japan in 2019. The market value
for DME treatments in these markets was estimated to be worth
between approximately $3.4 to $3.8 billion in 2019.
The market for DME therapies is dominated by
anti-VEGFs, which are the current standard of care. However, anti
VEGFs have been shown to deliver sub-optimal results in a
significant portion of the patient population. Around 40% of DME
patients have an unsatisfactory early visual response with
anti-VEGF therapy, and in many cases anti-VEGFs fail to achieve a
clinically meaningful visual improvement.
Oxurion is focused on solving these unmet
medical needs in diabetic eye disease.
Next generation therapies for improved outcomes in DME –
Beyond anti VEGF
Oxurion has developed a state-of-the-art
ophthalmology research and development model geared at identifying
and developing treatment methodologies for complex retinal diseases
with large unmet needs.
Oxurion’s R&D activities are focused on
using its in-depth understanding of important eye disease
mechanisms to generate new therapies that can be game changing in
the treatment of several major retinal indications such as diabetic
eye disease, including DME.
In general, treatment of diabetic eye disease is
centered around anti-VEGF therapies, which are used to treat
approximately 80% of patients. Despite the significant success of
anti-VEGFs, there will always be a need from both physicians and
patients for improved therapies that have:
- Faster onset of action
- Better therapeutic effect in terms of visual function, BCVA,
and response rate (proportion of patients)
- Longer duration of response allowing extended treatment
intervals
- Improved convenience of treatment through a simpler dosing
regimen
Those requirements are driving the development
of Oxurion’s new generation of therapies, beyond anti-VEGF.
Applying these criteria, Oxurion is developing
THR-687 and THR-149 to meet specific unmet needs in the market for
diabetic eye disease therapies.
Both candidates are being prepared to start
Phase 2 clinical trials.
Positive Phase 1 Results with THR-687
for the treatment of DME – Phase 2 program expected to start in H1
2021
Oxurion is developing THR-687, a novel pan-RGD
integrin antagonist, to preserve vision in 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 and other retinal
diseases.
Topline data from the Phase 1 trial showed that
THR-687:
- Is well-tolerated and safe with no dose-limiting toxicities. No
serious adverse events were reported at any of the doses evaluated
in the study.
- The study also looked at efficacy including changes to the
patient’s BCVA. Across all doses, a rapid onset of action as
measured by mean BCVA change was observed from Day 1 with an
increase of 3.1 letters, which further improved to 9.2 letters at
Month 1.
- This activity was maintained with a mean BCVA improvement of
8.3 letters at Month 3 following a single injection of THR-687.
- A clear dose response was seen in terms of BCVA with the
highest dose of THR-687 delivering a mean BCVA Improvement of 11
letters at Day 14, with a peak improvement of 12.5 letters at Month
3.
- In addition, a peak mean central subfield thickness (CST)
decrease of 106 µm was observed at Day 14 with the highest dose of
THR-687.
Data from this positive Phase 1 study with
THR-687 were presented by a leading retina expert at the Bascom
Palmer Eye Institute Angiogenesis, Exudation, and Degeneration 2020
Meeting in February 2020 in Miami (US).
Oxurion is preparing a Phase 2 study with
THR-687 which is expected to start in H1 2021.
THR-149 – a plasma kallikrein inhibitor
for treatment of DME
Positive Phase 1 Results with THR-149
for the treatment of DME – Phase 2 program expected to start as
soon as COVID-19 related safety considerations allow an efficient
study
THR-149 is a novel plasma kallikrein inhibitor
being developed as a potential new standard of care for the 40% of
DME patients who respond sub-optimally to anti-VEGF therapy.
THR-149 acts through inhibition of the Plasma
Kallikrein-Kinin (PKaI-Kinin) system, a validated target for
DME.
The Phase 1 study for THR-149 showed that
it:
- Is well-tolerated and safe. No dose-limiting toxicities nor
drug-related serious adverse events were reported at any of the
dosages evaluated in the study.
- Delivered promising results in relation to efficacy,
particularly improvements in the patient’s BCVA. A rapid onset of
action was observed from Day 1, with an increasing average
improvement in BCVA of up to 7.5 letters at Day 14.
Importantly, this activity was maintained with
an average improvement in BCVA of 6.5 letters at Day 90 following a
single injection of THR-149.
Data from this positive Phase 1 study with
THR-149 were presented at several major retina conferences in
Europe and the US in 2019, including the European Society of Retina
Specialists (EURETINA) in Paris and the Retina Society Annual
Meeting in London.
The Company is currently preparing to start a
Phase 2 development program, which will evaluate multiple doses of
THR-149 in patients with DME. This study is expected to start as
soon as COVID-19 related safety considerations allow an efficient
study to be undertaken.
This novel drug candidate was generated using
Bicycle Therapeutics’ Bicycles® technology platform.
Global commercial license agreement
for JETREA® signed allowing resources to be
focused on our next generation diabetic eye disease
pipeline
In March, Oxurion announced the signing of a
JETREA® global commercial license agreement with Inceptua
Group.
Inceptua Group is a global pharmaceutical
company and service partner spanning the product lifecycle – from
clinical trials, through early access programs to licensing and
commercialization of products. The Group has offices in Europe, the
US and Asia.
Financial Update
The Oxurion cash position (incl cash equivalents
& investments) at end of March 2020 was € 43.8 million.
This compares with €52.9 million at the end of December
2019.
END
For further information please
contact:
Oxurion NVWouter Piepers, Global Head of Investor Relations&
Corporate CommunicationsTel: +32 16 75 13 10 / +32 478 33 56
32wouter.piepers@oxurion.com |
Citigate Dewe Rogerson David Dible/ Sylvie Berrebi/ Frazer HallTel:
+44 20 7638 9571oxurion@citigatedewerogerson.com |
About Oxurion
Oxurion (Euronext Brussels: OXUR) is a
biopharmaceutical company developing next generation standard
ophthalmic therapies, which are designed to better preserve vision
in patients with diabetic eye disease, the leading cause of
blindness in people of working age worldwide.
Oxurion’s clinical pipeline comprises:
·THR-149, a
plasma kallikrein inhibitor being developed as a potential new
standard of care for DME patients who respond sub-optimally to
anti-VEGF
therapy. THR-149
has shown positive topline Phase 1 results for the treatment of
DME. The Company is currently preparing to conduct a Phase 2
clinical program, which is now expected to start as soon as
COVID-19 related safety considerations allow an efficient study.
THR-149 was developed in conjunction with Bicycle Therapeutics PLC
(NASDAQ:
BCYC) ·THR-687,
is a pan-RGD integrin inhibitor, that is initially being developed
as a potential new standard of care for all DME
patients Positive
topline results in a Phase 1 clinical study assessing it as a
treatment for DME were announced in January 2020. THR-687 is
expected to enter a Phase 2 clinical trial in H1 2021. THR-687 is
an optimized compound derived from a broader library of integrin
inhibitors in-licensed from Galapagos NV (Euronext & NASDAQ:
GLPG).
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.
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