OXURION Announces Positive Results from Part A of Phase 2 Study
Evaluating THR-149 for Treatment of Diabetic Macular Edema (DME)
Decision taken to move the highest dose
of THR-149 (0.13mg) into Part B of the study based on favorable
safety profile and positive efficacy data
Oxurion is moving into Part B of study
evaluating THR-149 against aflibercept
THR-149 is a potent plasma kallikrein
inhibitor for the treatment of the 40-50% of DME patients who
respond suboptimally to anti-VEGF therapy
Leuven, BE, Boston, MA, US –
September 30, 2021 – 07.00 AM CET – Oxurion NV
(Euronext Brussels: OXUR), a biopharmaceutical company developing
next generation standard of care ophthalmic therapies, today
announced positive data from Part A of its Phase 2 study
(“KALAHARI”) of THR-149, a plasma kallikrein inhibitor, for the
treatment of DME. Based on these data the Company has decided to
move the highest dose of THR-149 (0.13mg) into Part B of the study,
which is expected to begin shortly.
THR-149, is being developed as a potential new
standard of care intravitreal (IVT) therapy for the 40-50% of DME
patients showing suboptimal response to anti-VEGF therapy. THR-149
acts through inhibition of the plasma kallikrein-kinin (PKaI-Kinin)
system, a validated VEGF-independent target for DME.
Arshad M. Khanani, M.D., M.A.,
Director of Clinical Research at Sierra Eye Associates, Reno,
Nevada, US, comments: "I am excited to see the
results from Part A of the KALAHARI study, which was conducted in
patients who have shown suboptimal response to anti-VEGF
therapy. These patients currently have limited treatment options,
and the mean BCVA gains of + 6.1 letters at 3 months with
stable CST in patients treated with the highest dose of
THR-149 is encouraging. I am looking forward to
recruiting patients into Part B of this trial. I am hopeful
that the KALAHARI study will demonstrate that THR-149 could
benefit the 40-50% of DME patients who respond suboptimally to
anti-VEGFs."
The Phase 2 KALAHARI study is a two-part,
randomized, prospective, multi-center study assessing multiple
injections of THR-149 in DME patients who have previously shown a
suboptimal response to anti-VEGF therapy. The endpoints of Part A
of the study were safety (n= 23) and efficacy (n = 20).
In Part A of the study, three dose levels of
THR-149 (0.005mg, 0.022mg and 0.13mg), each administered in three
monthly IVT injections, were evaluated in order to select the best
dose for Part B of the study.
Results from Part A showed that all dose levels
of THR-149 had a favorable safety profile, with no serious adverse
events being observed. All adverse events in the study eye were
mild to moderate in intensity and no severe ocular adverse events
were reported.
Finally, no inflammation was seen in the study
eye of any patient at any dose evaluated in Part A of the
study.
When assessing efficacy, three IVT injections of
THR-149 (0.13mg) delivered the most promising results in terms of
Best Corrected Visual Accuity (BCVA), the primary endpoint for
registration in DME, and also delivered a stable Central Subfield
Thickness (CST), a promising result in a population were if left
untreated CST would be expected to deteriorate.
- No patients in the high dose group (n = 8) required rescue
medication.
- In terms of BCVA, the highest dose delivered a mean 6.1 letter
improvement at Month 3. The range of BCVA changes with the highest
dose was -0.4 to 12.6 letters at Month 3.
- In terms of CST, the highest dose showed a stable CST (mean
change of 13 µm) at Month 3. The range of CST changes with the
highest dose was -37.1 to 63.6 µm at Month 3.
Oxurion intends to present a more complete data
set from Part A of the KALAHARI study at an upcoming leading
ophthalmology conference.
Based on these data, the Company will shortly
start Part B of the study which will enroll just over one hundred
patients who have previously shown a suboptimal response to
anti-VEGF therapy, and where THR-149 will be evaluated against
aflibercept, the current standard of care, as the active
comparator.
Final topline results from the KALAHARI study
are expected by mid-2023.
Tom Graney, CFA, Chief Executive Officer
of Oxurion, comments, “The positive data from Part A of
the KALAHARI study provides proof of concept for multiple
injections of THR-149 in this important DME patient population and
is a significant de-risking event for the Company. We are pleased
to be able to proceed into the second part of the study, where we
hope to confirm THR-149’s ability to address the significant unmet
need in this patient population that experiences a suboptimal
response to anti-VEGFs and currently lacks adequate treatment
options. I would like to thank the patients, physicians, and the
clinical teams for their support in completing Part A of this
important study. These very encouraging results with THR-149,
alongside the initiation of our Phase 2 (“INTEGRAL”) study with
THR-687, a pan-RGD integrin antagonist, being developed as a
potential first line therapy for DME patients, gives Oxurion one of
the most exciting pipelines in ophthalmology today.”
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 9304
chris.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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