OXURION Completes Patient Enrollment for Part A of Phase 2 Study Evaluating THR-149 for Treatment of Diabetic Macular Edema (...
08 Giugno 2021 - 7:00AM
OXURION Completes Patient Enrollment for Part A of Phase 2 Study
Evaluating THR-149 for Treatment of Diabetic Macular Edema (DME)
THR-149 is a potent plasma kallikrein
inhibitor for the treatment
of DME in
the roughly 40%
of the patient
population
responding
suboptimally to anti-VEGF
therapy
Leuven,
BE, Boston, MA,
US – June
8,
2021 –
07.00
AM CET – Oxurion NV (Euronext
Brussels: OXUR), a biopharmaceutical company developing next
generation standard of care ophthalmic therapies, today announced
the completion of patient enrollment into Part A of its two part
Phase 2 study (“KALAHARI”) evaluating multiple injections of
THR-149 for the treatment of DME. Dose selection data from Part A
of the study is expected in the second half of 2021.
THR-149, Oxurion’s most advanced drug candidate,
is being developed to potentially become the treatment of choice
for the up to 40% of DME patients, who respond suboptimally to
anti-VEGF therapy. THR-149 acts through inhibition of the plasma
kallikrein-kinin (PKaI-Kinin) system, a validated VEGF-independent
target for DME.
A single dose Phase 1 study showed that THR-149
was well-tolerated, safe and delivered promising efficacy results,
particularly improvements in patients’ Best Corrected Visual Acuity
(BCVA) the primary endpoint for registration in DME. A rapid onset
of action was observed from Day 1, across all doses, with an
increasing average improvement in BCVA of up to 7.5 letters at Day
14. Importantly, this visual gain was maintained with an average
improvement in BCVA of 6.4 letters at Day 90.
The Phase 2 KALAHARI study is a two part,
randomized, prospective, multi-center study assessing multiple (3)
injections of THR-149 in DME patients who suboptimally respond to
anti-VEGF therapy. In Part A of the study, three dose levels of
THR-149, each administered in 3 monthly intravitreal injections,
are being tested in at least 18 patients to select the optimal dose
for Part B.
Tom Graney,
CFA, Chief Executive Officer of
Oxurion, comments, “We are very pleased to announce the
completion of patient enrollment into Part A of our Phase 2 study
evaluating THR-149 for the treatment of DME, particularly given the
challenges posed by the continuing Covid-19 situation. This
milestone positions us to report the important initial Part A data
in the second half of the year. These data, if positive, will
provide proof of concept and be a significant derisking event for
the company. This patient population currently does not have
adequate treatment options and represents a critical area of unmet
medical need in the treatment of diabetic macular edema.”
Part B (n≈104) is the double-masked,
active-controlled part of the study with the dose selected from
Part A studied against aflibercept as the active comparator. Final
topline results from Part B of the study are expected in the first
half of 2023.
END
For further information please contact:
Oxurion NVWouter Piepers, Global Head of Investor Relations&
Corporate CommunicationsTel: +32 478 33 56
32wouter.piepers@oxurion.com |
EU Citigate Dewe Rogerson David Dible/ Sylvie Berrebi/Frazer
HallTel: +44 20 7638
9571oxurion@citigatedewerogerson.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 the leading global
franchise in the treatment of retinal vascular disorders based on
the successful development of its two novel therapeutics:
- THR-149, a plasma kallikrein
inhibitor being developed as a potential new standard of care for
the 40% of DME patients who respond suboptimally 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 who previously responded suboptimally to anti-VEGF
therapy.
- 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. THR-687 is expected to enter a Phase 2 clinical
trial in mid-2021. THR-687, also has the potential to deliver
improved treatment outcomes for patients with wet AMD and RVO.
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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