Oxurion NV – Expert Presentation of Positive Topline Data from a
Phase 1 Study evaluating THR-687 for the treatment of DME,at
Angiogenesis, Exudation, and Degeneration 2020 Conference
Oxurion NV – Expert Presentation of
Positive Topline Data from a Phase 1 Study evaluating THR-687 for
the treatment of DME,at Angiogenesis, Exudation,
and Degeneration 2020 Conference
Phase 2 study with THR-687 in treatment
naïve DME patients to start in H2 2020
Leuven, Belgium, 9 February
2020 – Oxurion NV (Euronext Brussels: OXUR), a
biopharmaceutical company developing next generation therapies
designed to treat patients with diabetic eye disease, today
announces that further positive topline data from a Phase 1 study
with THR-687, a novel, potent, pan-RGD integrin antagonist for the
treatment of Diabetic Macular Edema (DME) was presented by Arshad
Khanani, M.D., M.A., Director of Clinical Research at Sierra Eye
Associates, Reno, Nevada, US at the Angiogenesis, Exudation, and
Degeneration 2020 conference on February 8,
2020, in Miami, US.
The Angiogenesis, Exudation, and Degeneration
2020 conference, organized by the world-renowned Bascom Palmer Eye
Institute, featured an exceptional gathering of scientists,
clinicians, and healthcare experts, all focused on understanding
and treating neovascular and exudative diseases of the eye.
Arshad Khanani, M.D.,
M.A., Director of Clinical Research at Sierra Eye Associates, Reno,
Nevada, US and one of the clinical investigators
of the THR-687 Phase 1 study,
commenting on his presentation said, “I am
delighted to have the opportunity to present these exciting THR-687
data at one of the most reputed global retina meetings. The topline
Phase 1 data showed that THR-687 was safe and well tolerated at all
of the dose levels tested. The study also demonstrated that THR-687
had a rapid positive effect on Best Corrected Visual Acuity (BCVA)
that was durable for up to 3 months following just one single
injection. I believe that these initial findings are very promising
and further studies are needed to confirm the efficacy and safety
of THR-687 in patients with DME.”
The Phase 1, open-label, multi-center (US),
single dose escalation study evaluated the safety of a single
intravitreal injection of 3 increasing doses of THR-687 (0.4
mg, 1.0 mg, 2.5 mg) for the treatment of DME (NCT 03666923).
Patients recruited into the study had a history of response to
prior anti-VEGF and/or corticosteroid treatment and remained
responsive to treatment according to the investigator
assessment.
Topline data from the trial showed that THR-687
was 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 in mean BCVA 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 with the greatest
positive effect on BCVA with the highest dose of THR-687. For
this highest dose, a mean BCVA Improvement of 11.2 letters was
noted at Day 14, with a peak mean improvement of 12.5 letters at
Month 3. Further, a peak mean CST (Central Subfield Thickness)
decrease of 106 µm was observed at Day 14 with the highest dose of
THR-687.
Patrik De Haes, M.D., CEO of
Oxurion, said: “These encouraging findings from our Phase
1 study with THR-687, along with the very positive feedback we have
received from the retinal community, highlight the significant
potential of this novel integrin antagonist. We are on track to
start a Phase 2 clinical study with THR-687 in treatment naïve DME
patients in H2 2020.”
The presentation made by Arshad Khanani, M.D.,
M.A., at the Angiogenesis, Exudation, and Degeneration 2020
Conference can be found here.
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 of
care 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 expected to start in H1 2020.
THR-149 was developed in conjunction with Bicycle Therapeutics plc
(NASDAQ:BCYC) -
THR-687, is a pan-RGD integrin inhibitor, that is 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 H2 2020. 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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