Oxurion Announces New Data on THR-149 Phase 2 Clinical Trial (“KALAHARI”) in DME at the Angiogenesis, Exudation, and Degeneration 2022 Conference
February 14 2022 - 2:00AM
Oxurion Announces New Data on THR-149 Phase 2 Clinical Trial
(“KALAHARI”) in DME at the Angiogenesis, Exudation, and
Degeneration 2022 Conference
- Post-hoc analysis reveals >9 letter gain in mean
BCVA that was maintained for the remaining four months of the trial
after the last THR-149 injection with no rescue treatment
required
- These gains were seen in patients that are part of the
40-50% of DME patients that suboptimally respond to standard of
care ant-VEGF therapy
Leuven, BELGIUM, Boston, MA, US – 14
February 2022 – 8.00 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, presented new data
from Part A of its two-part Phase 2 Clinical Trial (“KALAHARI”)
assessing THR-149 for treatment of diabetic macular edema (DME) at
the Angiogenesis, Exudations, and Degeneration 2022 Meeting on
February 11-12th.
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.
High-level Month 3 data from Part A of the KALAHARI trial was first
presented in October 2021 and demonstrated that in the 8 patients
who received the highest dose of THR-149, a mean BCVA gain of 6.1
letters at Month 3, the primary endpoint, was observed.
The new data reviewed today is a post-hoc
analysis of an OCT (Optical Coherence Tomography) biomarker
assessment, which was performed by the masked central reading
center. The masked reading center identified two subjects with
abnormalities at baseline, which could impact responsiveness to
treatment. Excluding these two subjects resulted in an improvement
in mean BCVA of 9.3 letters at Month 3 that was sustained until
Month 6, the end of the trial. The six-month data also demonstrated
THR-149’s attractive safety profile and its ability to stabilize
the Central Subfield Thickness (CST).
“The data presented today continues to highlight
THR-149’s compelling safety and efficacy profile in patients with
diabetic macular edema,” commented Arshad M. Khanani, M.D.,
M.A., Director of Clinical Research at Sierra Eye Associates, Reno,
Nevada, US. “For patients who are suboptimal responders to
standard of care anti-VEGF therapy, the post-hoc analysis of the
high-dose cohort in the KALAHARI trial showed encouraging gains in
BCVA with over 80% of patients gaining at least 5 letters and 50%
of patients gaining at least 10 letters four months after the last
THR-149 injection. In addition, CST was stable up to Month 6. These
results demonstrate the potential of THR-149 to make a meaningful
difference to this patient population, which if left untreated
would be expected to experience a further deterioration in their
vision.”
Based on Month 3 Part A data, the high dose of
THR-149 was selected for Part B of the KALAHARI study to compare
vs. aflibercept for the treatment of DME. The learnings from the
Part A data presented today have already been incorporated into
Part B through an amended study design, which has been approved by
the US IRB. The approved protocol amendment optimizes the inclusion
and exclusion criteria for Part B and eliminates subjects with
potential baseline abnormalities, to further increase the potential
for response to treatment. Part B of the trial is currently
enrolling with topline data expected mid-2023.
Tom Graney, CFA, Chief Executive Officer
of Oxurion, said, “The data Dr. Khanani presented improves
our understanding of which patients are most likely to respond to
treatment and underscores the potential of THR-149 to address the
significant unmet need in patients that experience a suboptimal
response to anti-VEGFs and currently lack adequate treatment
options. We believe these changes will maximize our ability to
achieve a successful trial outcome to the benefit of patients while
preserving the positive attributes of the initial trial design and
maintaining our timelines.”
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 assessed 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.
All dose levels of THR-149 demonstrated a
favorable safety profile during Part A of the KALAHARI trial, which
was maintained through the end of the trial. All adverse events in
the study eye were mild to moderate in intensity and no severe
ocular adverse events were reported and no intra-ocular
inflammation observed.
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-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-687 is a
highly selective pan-RGD integrin antagonist that is being
developed as a potential first line therapy for DME patients as
well as wAMD and ME-RVO. Oxurion is headquartered in Leuven,
Belgium, with corporate operations in Boston, MA. 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.
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 |
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