OXURION - Positive Phase 2 Part A THR-149 data shared at the America Society of Retinal Specialists (ASRS) Annual Scientific Meeting
October 11 2021 - 1:00AM
OXURION - Positive Phase 2 Part A THR-149 data shared at the
America Society of Retinal Specialists (ASRS) Annual Scientific
Meeting
- Patients in the highest dose group achieved an overall mean 6.1
letter improvement in Best Corrected Vision (BCVA) at Month 3, of
which:
- 63% showed at least a 5-letter gain
- 38% achieved at least a 10-letter gain
- 13% achieved at least a 15-letter gain
- Oxurion intends to present a more complete data set from Part A
of the KALAHARI study at an upcoming leading ophthalmology
conference
Leuven, BE, Boston, MA,
US – October 11,
2021 – 07.00 AM CET – Oxurion NV
(Euronext Brussels: OXUR), a biopharmaceutical company developing
next generation standard of care ophthalmic therapies, is delighted
to announce that further characterization of the BCVA data from the
previously reported Part A portion of the Phase 2 (“KALAHARI”)
study of THR-149 was shared at the American Society for Retinal
Specialists (ASRS) Annual Scientific Meeting.
THR-149 is a plasma kallikrein inhibitor, being
developed for the treatment of the 40-50% of DME patients who
sub-optimally respond to standard of care anti-VEGF therapy.
As previously announced, results from Part A
demonstrated that all dose levels of THR-149 had a favorable safety
profile. All adverse events in the study eye were mild to moderate
in intensity and no severe ocular adverse events were reported and
no inflammation observed.
The highest dose of THR-149 (0.13mg) produced
the largest improvement in BCVA, the primary endpoint for
registration in DME studies. The highest dose delivered a mean 6.1
letter improvement at Month 3 with no patients requiring rescue
medications.
Further characterization of the BCVA data was
shared yesterday during ASRS by Arshad M. Khanani,
M.D., M.A., Director of Clinical Research at Sierra Eye Associates,
Reno, Nevada, US, “I am happy to report
that in patients, who had been suboptimally treated with anti-VEGF
therapy, the highest dose of THR-149 was able to achieve at least a
5-letter gain in 63% of patients, of these 38% patients achieved at
least a 10-letter gain, and 13% saw at least a 15-letter gain. In
addition, CST was stable and a change of 13 µm observed at Month 3.
These results demonstrate the potential of THR-149 to make a real
difference to this patient population, which if left untreated
would be expected to see a further deterioration in their
vision.”
Tom Graney, CFA, Chief Executive Officer
of Oxurion, comments, “These data provide proof of concept
for multiple injections of THR-149, our potent plasma kallikrein
inhibitor, in this important underserved DME patient population. We
are very excited that in these patients, who currently do not have
suitable treatment options, over 60% gained at least a full line
improvement in vision from baseline when treated with the highest
dose of THR-149.”
In Part B of this study, we hope to confirm
THR-149’s ability to address the significant unmet need in this
large patient population that experience a suboptimal response to
anti-VEGFs and as a result currently lack adequate treatment
options.”
Based on the results from Part A of the Phase 2
study, the Company is advancing the high dose of THR-149 (0.13mg)
into 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 in mid-2023.
Oxurion intends to present a more complete data
set from Part A of the KALAHARI study at an upcoming leading
ophthalmology conference.
END
For further information please
contact:
Oxurion NV Tom 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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