Oxurion NV Announces First Patient Dosed in its Phase 2 Study
Evaluating THR-687 for the treatment of Diabetic Macular Edema
(DME)
- THR-687 is a potent pan-RGD integrin antagonist holding
potential as a next generation first line therapy for DME,
currently a $4.5 billion market opportunity
- THR-687 also holds promise for treatment of wet AMD
(Age-related Macular Degeneration) and RVO (Retinal Vein Occlusion)
thereby expanding the combined addressable annual market potential
to $12 billion
Leuven, BE, Boston, MA, US – October 13, 2021 – 07.00 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 first patient has
been dosed in its Phase 2 clinical study evaluating THR-687 in
patients with Diabetic Macular Edema (DME) (study name
“INTEGRAL”).
Tom Graney, CFA, Chief Executive Officer
of Oxurion, comments: “We are delighted to have dosed the
first patient in Part A of this important Phase 2 clinical trial
designed to assess multiple doses of THR-687 in treatment naïve
patients suffering from DME. We believe that THR-687, based on its
differentiated mode of action and the data generated to date, has
the potential to become a first line treatment option for DME
patients who require much better clinical outcomes. Beyond DME,
THR-687 also holds promise to improve the standard of care of
patients with wet AMD and RVO, altogether unlocking a $12 billion
annual market opportunity. In addition to this important milestone
with THR-687, we have recently announced positive Phase 2 data from
Part A of the KALAHARI study evaluating THR-149 in patients who
have responded suboptimally to anti-VEGF therapy, which could allow
us to grow the $4.5 billion DME market. With THR-687 and THR-149,
Oxurion has the potential to help millions of patients with eye
disease achieve improved vision and to create significant value for
our shareholders.”
The INTEGRAL study is a Phase 2, randomized,
multicenter trial and is the first study in which multiple
intravitreal injections of THR-687 will be administered in
humans.
The two-part study will assess two dose levels
of multiple THR-687 injections (Part A) and, if successful, go on
to evaluate the efficacy and safety of THR-687 versus aflibercept
(the current standard of care) for the treatment of DME (Part
B).
Part A is being conducted in treatment naïve
subjects to select the optimal THR-687 dose level to be assessed in
Part B.
Part B will be conducted in both treatment naïve
and treatment experienced subjects to evaluate the efficacy and
safety of THR-687 compared to aflibercept.
The primary efficacy endpoint of the study in
Part B is the change in Best Corrected Visual Acuity (BCVA) from
baseline at Month 3.
The dose selection decision, following Part A,
is anticipated in the first half of 2022 with top line data from
Part B expected in the second half of 2023.
Arshad M. Khanani, M.D., M.A., Director
of Clinical Research at Sierra Eye Associates, Reno, Nevada,
US, said, “I am very pleased to be a part of this
important Phase 2 study assessing multiple doses of THR-687 in
treatment naïve patients with DME. My enthusiasm for THR-687 is
based on the unique mechanism of action and my earlier involvement
in the Phase 1 study, which showed THR-687 was well-tolerated and
showed an encouraging efficacy signal with a single dose. The novel
mechanism of THR-687 is exciting and it has the potential to become
the first line treatment of choice for the 28 million patients
worldwide who suffer with DME.”
Oxurion has already generated positive data from
a Phase 1, open-label, multicenter (US), single dose escalation
study evaluating the safety of a single intravitreal injection of 3
dose levels (0.4 mg, 1.0 mg, 2.5 mg) of THR-687 for the treatment
of DME.
A single injection of THR-687 was safe and
well-tolerated, showing a very encouraging efficacy signal. 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. The mean BCVA improvement was maintained
with 8.3 letters gain at Month 3 following a single injection of
THR-687.
A 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.
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).
END
For further information please
contact:
Oxurion NVTom GraneyChief Executive OfficerTel: +32 16 75 13
10tom.graney@oxurion.com Michael DillenChief Corporate
DevelopmentTel: +32 479 783583Michael.dillen@oxurion.com
|
EU MEDiSTRAVA ConsultingDavid Dible/ Sylvie Berrebi/Frazer HallTel:
+44 20 7638 9571oxurion@medistrava.com USWestwicke, an ICR
CompanyChristopher BrinzeyTel: +1 617 835
9304chris.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 highly selective 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
(“INTEGRAL”) 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 potent 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
(“KALAHARI”) evaluating multiple injections of THR-149 in DME
patients previously showing a suboptimal response to anti-VEGF
therapy. Following positive data from Part A of this Phase 2 study
(dose selection), the Company has initiated Part B of the
study.
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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