Oxurion NV - Publication of Positive Phase 1 Clinical Data evaluating THR-687 for Treatment of DME in Ophthalmology Science, the American Academy of Ophthalmology Journal
17 Août 2021 - 8:00AM
Oxurion NV - Publication of Positive Phase 1 Clinical Data
evaluating THR-687 for Treatment of DME in Ophthalmology Science,
the American Academy of Ophthalmology Journal
THR-687 is a potent pan-RGD integrin
antagonist holding potential as next generation first line therapy
for DME, wet AMD and RVO
Phase 2 Clinical Study THR-687 in DME
currently recruiting patients
Leuven, BE, Boston, MA, US – August 17, 2021
– 08.00 AM CET - Oxurion NV (Euronext Brussels: OXUR), a
biopharmaceutical company developing next generation standard of
care ophthalmic therapies, with a clinical stage portfolio in
vascular retinal disorders, announces that the positive Phase 1
study of THR-687, a novel, highly potent integrin agonist for the
treatment of DME has just been published in Ophthalmology Science,
the journal of the American Academy of Ophthalmology.
The multicenter, dose escalation study was
designed to evaluate the safety and preliminary efficacy of three
dose levels of THR-687 (0.4, 1.0 or 2.5mg) in subjects with
center-involved DME following a single intravitreal injection.
As reported from the top line data in 2020, a
single injection of THR-687 was safe and well tolerated, showing a
very encouraging efficacy signal as measured by a rapid gain in
BCVA with three months durability and a decrease in CST up to one
month following the injection.
A clear dose response was seen with the greatest
positive effect on BCVA and Central Subfield Thickness (CST) with
the highest dose of THR-687. For this highest dose, a mean
BCVA Improvement of 11 letters was noted at Day 14, with a peak
improvement of 12.5 letters at Month 3. Similarly, a peak mean CST
decrease of 106 µm was observed at Day 14 with the highest dose of
THR-687.
THR-687 will next be investigated in the
INTEGRAL Phase 2 study, a randomized, multicenter trial in DME.
This is the first trial in which multiple intravitreal injections
of THR-687 will be administered in humans. The two-part study will
assess different dose levels of multiple THR-687 injections (Part
A) and then go on to evaluate the efficacy and safety of the
selected dose of THR-687 versus aflibercept (the current standard
of care) for the treatment of DME (Part B).
The dose selection decision, following Part A,
is anticipated in the first half of 2022 and top line data from
Part B is expected in the second half of 2023. Tom
Graney, CFA, CEO of Oxurion comments, “I am pleased that the
significance of the Phase 1 THR-687 data has been recognised by its
publication in the prestigious American Academy of Ophthalmology
journal. The highly promising results from just a single dose of
THR-687 have warranted the planning of the Phase 2 study which just
opened enrolment of patients. There remains a significant unmet
medical need in DME and THR-687 has the potential to be a
transformative first line therapy for the many patients suffering
from this serious condition. We would like to thank the patients
for their participation in the Phase 1 study as well as the
world-class investigators that worked on the trial and the
publication.”
Beyond DME, THR-687 has the potential to be
developed for additional vascular retinal disorders including for
wet Age-related Macular Degeneration (wet AMD) and retinal vein
occlusion (RVO). These additional indications, alongside DME, mean
that THR-687, is targeting a total market opportunity estimated to
be worth $12+ billion annually.
Article can be accessed at:
https://doi.org/10.1016/j.xops.2021.100040
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 |
EU MEDiSTRAVA ConsultingDavid Dible/ Sylvie Berrebi/Frazer HallTel:
+44 20 7638 9571oxurion@medistrava.com-USWestwicke, an ICR
CompanyChristopher BrinzeyTel: +1 617 835
9305chris.brinzey@westwicke.com |
About Oxurion
Oxurion (Euronext Brussels: OXUR) is a
biopharmaceutical company developing next generation standard of
care ophthalmic therapies, which are designed to better preserve
vision in patients with retinal vascular disorders including
diabetic macular edema (DME), the leading cause of vision loss in
diabetic patients worldwide as well as other conditions, including
wet age-related macular degeneration (AMD) and retinal vein
occlusion (RVO). Oxurion is aiming to build a leading global
franchise in the treatment of retinal vascular disorders based on
the successful development of its two novel therapeutics:
-
THR-687 is a pan-RGD integrin antagonist that is initially being
developed as a potential first line therapy for DME patients.
Positive topline results in a Phase 1 clinical study assessing
THR-687 as a treatment for DME were announced in 2020. Oxurion is
currently conducting a Phase 2 clinical trial evaluating THR-687 in
patients with DME. THR-687 also has the potential to deliver
improved treatment outcomes for patients with wet AMD and RVO.
-
THR-149 is a plasma kallikrein inhibitor being developed as a
potential new standard of care for the 40-50% of DME patients
showing suboptimal response to anti-VEGF therapy. THR-149 has shown
positive topline Phase 1 results for the treatment of DME. The
company is currently conducting a Phase 2 clinical trial evaluating
multiple injections of THR-149 in DME patients previously showing
suboptimal response to anti-VEGF therapy. Dose selection data from
Part A of the study, which is fully enrolled, is expected in the
second half of 2021.
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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