Oxurion Provides Update on Clinical Pipeline Progress
Completed Patient Enrollment for Part A of Phase
2 INTEGRAL Trial Evaluating THR-687 for treatment of Diabetic
Macular Edema (DME) in treatment naïve subjects
US IRB Approval of Protocol Amendment to Part B
of the Phase 2 KALAHARI Trial Assessing THR-149 versus aflibercept
for treatment of DME in patients that suboptimally respond to
anti-VEGF therapy
Full dataset from Part A of KALAHARI Trial to be
presented at Angiogenesis on February 12th
Leuven,
BELGIUM, Boston,
MA, US – 7 January
2022 – 7.00 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, today announced updates on its two
clinical programs, THR-687, initially being developed for first
line treatment of DME, and THR-149 being developed for second line
treatment of DME.
THR-687 – Completed
Patient Enrollment for Part A of the Phase 2
Clinical Trial
(“INTEGRAL”)
Evaluating THR-687 in Patients with
DME
THR-687 is a potential best-in-class small
molecule pan-RGD integrin antagonist being developed for the
treatment of DME and holding promise for the treatment of wet
Age-related Macular Degeneration (wAMD) and macular edema following
Retinal Vein Occlusion (RVO). The INTEGRAL trial is a two-part
Phase 2, randomized, multi-center clinical trial and is the first
trial in which multiple intravitreal injections of THR-687 will be
administered in humans.
“We are pleased to announce the completion of
patient enrollment for Part A of the Phase 2 INTEGRAL trial of
THR-687,” Tom Graney, CFA, Chief Executive Officer of
Oxurion commented. “The rapid enrollment
in this trial is a testament to how interested physicians and
patients are to have a new mechanism of action with the potential
to offer improved efficacy over the standard of care anti-VEGF
therapy. This milestone brings us closer to delivering a potential
first line treatment of choice for patients with DME. With its
unique mechanism of action, THR-687 demonstrated promising results
in its Phase 1 study, which showed an encouraging efficacy signal
following just a single dose. This best-in-class small molecule has
further potential to be developed to raise the standard of care in
additional significant indications, including wAMD and RVO.”
Part A of the trial will assess two dose levels
of multiple THR-687 injections and, if successful, the trial’s
results will be used to select the appropriate dose for Part B of
the INTEGRAL trial that will evaluate the efficacy and safety of
THR-687 versus aflibercept (the current standard of care) for the
treatment of DME. Part B of the trial will include both treatment
experienced and treatment naïve subjects.
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.
THR-149 – Received Approval from
the US Institutional Review
Board (IRB) to Amend
the Protocol for
Part B of the Phase 2 Clinical Trial
(“KALAHARI”)
Assessing THR-149 versus aflibercept for Treatment
of DME
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.
The trial’s U.S. IRB has approved a protocol
amendment to Part B of its ongoing KALAHARI trial assessing
multiple doses of THR-149 versus aflibercept for the treatment of
DME. The changes to the protocol are designed to:
- Enhance the probability of a
successful trial outcome without impacting the trial timelines by
refining the patient inclusion/exclusion criteria, and
- Provide preliminary data on the use
of THR-149 before, or immediately following, anti-VEGF therapy by
exploring synergies of THR-149 with aflibercept utilizing a
cross-over style design with a fourth injection at month four
In September 2021, Oxurion announced positive
data from Part A of the Phase 2 KALAHARI trial evaluating THR-149
for the treatment of DME. These data demonstrated that THR-149 had
a favorable safety profile, with no serious adverse events or
inflammation observed at any dose level. The high dose achieved a
mean improvement in Best Corrected Vision (BCVA) of 6.1 letters at
Month 3 without the need for rescue medication. BCVA is the primary
endpoint for registration in DME trials.
The post-hoc analysis of the Part A results
identified opportunities to optimize the inclusion and exclusion
criteria for Part B for both probability of success and speed. Part
B of the KALAHARI trial is ongoing, assessing three monthly
injections of THR-149, compared to three monthly injections of
aflibercept, up to Month 3. As from Month 3, the safety and
efficacy of a switched fourth injection (THR-149 to aflibercept or
aflibercept to THR-149) will be evaluated in about half of the
subjects whereas in the other half of the subjects the durability
of three monthly injections (THR-149 or aflibercept) will be
evaluated through a single sham injection. The trial is planned to
randomize approximately 108 subjects in Part B and the primary
endpoint remains the mean change in BCVA letter score from
baseline, at Month 3.
Tom Graney, CFA, Chief Executive Officer
of Oxurion, said, “I am pleased that the IRB has approved
our protocol amendments to Part B of the Phase 2 KALAHARI trial.
These amendments, including refining the patient inclusion and
exclusion criteria, have been made based on further post-hoc
analyses of the data from Part A of the trial, which have improved
our understanding of which patients are most likely to respond to
treatment with THR-149. We believe these changes will maximize our
ability to achieve a successful trial outcome while preserving the
benefits of the initial trial design and maintaining our
timelines.”
Additional new data from Part A from the
KALAHARI trial will be presented at Angiogenesis, Exudation, and
Degeneration 2022, a virtual conference taking place February 11
and 12, 2022. Arshad M. Khanani, M.D., M.A., Director of Clinical
Research at Sierra Eye Associates, Reno, Nevada, US will present
the Part A data on February 12th.
Final topline results from Part B the KALAHARI
trial are expected by mid-2023.
END
For further information please
contact:
Oxurion NVTom GraneyChief Executive OfficerTel: +32 16 75 13
10tom.graney@oxurion.com Michael DillenChief Business
OfficerTel: +32 479 783583michael.dillen@oxurion.com |
EU MEDiSTRAVA ConsultingDavid Dible/ Sylvie Berrebi/Frazer HallTel:
+44 203 928 6900oxurion@medistrava.com USICR
WestwickeChristopher 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 (wAMD) 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 wAMD 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 trial
(dose selection), the Company has initiated Part B of the
trial.
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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