Oxurion NV Reports First Patient Dosed in Phase 2 study evaluating
THR-149 for treatment of Diabetic Macular Edema (DME)
Oxurion NV Reports First Patient Dosed in
Phase 2 study evaluating THR-149 for treatment of Diabetic Macular
Edema
(DME)
THR-149 is a potent plasma kallikrein
inhibitor in development for DME for up to 40% of
patients who respond sub-optimally to anti-VEGF
therapy.
- Part A of the study will assess the optimal dose from 3
different dose levels of 3 THR-149 injections – read out
anticipated around mid-2021
- Part B of the study will then evaluate the efficacy and safety
of the selected optimal dose of THR-149 versus aflibercept for the
treatment of DME – read out anticipated in first half of 2023
Leuven,
Belgium, 1 September – 07.00 AM CET – Oxurion NV (Euronext
Brussels: OXUR), a biopharmaceutical company engaged in the
development of next-generation therapies to treat diabetic eye
disease, with a focus on Diabetic Macular Edema, today reports that
the first patient has been dosed in its two-part Phase 2 study
(“KALAHARI”) evaluating THR-149 for the treatment of DME. THR-149
acts through inhibition of the Plasma Kallikrein-Kinin (PKaI-Kinin)
system, a validated VEGF independent target for DME.
In a Phase 1 study reported in mid-2019, THR-149 was shown to be
well-tolerated and safe. No dose-limiting toxicities nor
drug-related serious adverse events were reported at any of the
dosages evaluated in the study.
The Phase 1 study also delivered promising results in relation
to efficacy, particularly improvements in patients’ Best Corrected
Visual Acuity (BCVA). 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
following a single injection of THR-149.
The Phase 2, with study name ‘KALAHARI’, is a randomised,
prospective, multi-centre study assessing multiple (3) injections
of THR-149 in 2 parts. Part A (n=18) is a single-masked,
dose-finding part of the study assessing 3 dose levels of THR-149
to select the optimal dose for Part B. Part B (n≈104)
is the double-masked, active-controlled part of the study with 1
dose level of THR-149 and aflibercept as comparator.
The study will recruit approximately 122
patients with central-involved DME who sub-optimally respond to
anti-VEGF across the two parts of the study, with Part A data
expected by mid 2021, and top line results from Part B expected in
the first half of 2023.
Charles C. Wykoff, M.D., Ph.D.,
board-certified Medical and Surgical Retina Specialist and
Director of Research at Retina Consultants of Houston, and
principal investigator of the study said: “Starting this clinical
trial is an important step towards potentially bringing THR-149, a
novel and promising plasma kallikrein inhibitor, to patients with
DME. DME is a leading cause of adult visual loss globally and new
approaches are needed for the up to 40% of patients who do not
respond optimally to anti-VEGF monotherapy. These patients may
benefit from therapeutics with new mechanisms of action such as
inhibition of plasma kallikrein. THR-149 has shown encouraging
early clinical data and I look forward to the results from this
robust Phase 2 clinical study.”
Grace Chang, M.D., Ph.D., Chief Medical
Officer of Oxurion, said: “We are delighted to announce
the recruitment of the first patient into this Phase 2 study with
THR-149 in DME, which we have been able to start safely, taking
into account the necessary Covid-19 precautions. The data from the
Phase 1 study with THR-149 showed that it delivered promising
efficacy results in relation to BCVA after a single injection as
well as having a rapid onset of action. We believe that this Phase
2 study will further elucidate the clinical benefits that THR-149
could deliver for patients with DME.”
Patrik De Haes, M.D., CEO of
Oxurion, said: “We believe that THR-149 has the potential
to become an important therapy for the large number of patients
that have failed to optimally respond to anti-vascular endothelial
growth factor (VEGF) therapies.
The start of this Phase 2 trial is a major step
in our plans to build a DME franchise based on the successful
development of THR-149 and THR-687 for specific, complementary
target patient groups. By successfully developing these two novel
therapeutic candidates, we have the potential to transform the
treatment of DME patients globally.”
Oxurion’s emerging DME franchise will be based
on the successful development of both THR-149 and THR-687 two novel
therapeutics with different modes of action designed for specific
complementary target patient groups:
- Oxurion’s most advanced new drug candidate, THR-149 is being
developed to potentially become the treatment of choice for DME
patients with persistent edema who are currently sub-optimally
responding to anti-VEGF therapy
- Oxurion’s second drug candidate targeting DME, THR-687 is
expected to enter Phase 2 development in 2021. This potentially
best-in-class pan-RGD integrin antagonist has the potential to
become the standard of care for treatment-naïve patients by
replacing anti-VEGF’s as the mainstay of DME therapy today.
Oxurion is confident that with both THR-687 and
THR-149 it will be able to provide new tailored therapeutic
solutions that deliver improved clinical outcomes to almost all DME
patients.
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
ophthalmic therapies, which are designed to better preserve vision
in patients with diabetic macular edema (DME), the leading cause of
vision loss in diabetic patients worldwide.
Oxurion is building a leading global franchise
in the treatment of DME, 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 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 conducting a Phase 2 clinical
trial (“KALAHARI”) evaluating THR-149 with DME-patients who
previously responded sub-optimally to anti-VEGF therapy. THR-149
was developed in conjunction with Bicycle Therapeutics PLC (NASDAQ:
BCYC)
- THR-687, is a pan-RGD integrin inhibitor, that is initially
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 by mid 2021. 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.
Grafico Azioni Oxurion NV (EU:OXUR)
Storico
Da Mar 2024 a Apr 2024
Grafico Azioni Oxurion NV (EU:OXUR)
Storico
Da Apr 2023 a Apr 2024