Oxurion Announces Interim Analysis for KALAHARI Trial
18 Noviembre 2022 - 3:00PM
Oxurion Announces Interim Analysis for KALAHARI Trial
Interim
Analysis for KALAHARI trial
planned by Year-End 2022
with Full
Top-Line Data
Expected in
Second half of
2023
Leuven, BELGIUM, Boston, MA, US
– November
18, 2022
– 10:00
PM CET Oxurion NV (Euronext
Brussels: OXUR) a biopharmaceutical company developing next
generation standard of care ophthalmic therapies, with clinical
stage assets in vascular retinal disorders, today announced it is
planning an interim analysis of at least 25% of the patients for
the KALAHARI Phase 2, Part B clinical trial. Results of the interim
analysis are expected by year-end 2022 and full top-line data from
the trial is now expected in the second half of 2023.
The KALAHARI trial is evaluating Oxurion’s novel
plasma kallikrein (PKal) candidate, THR-149, as a potential
treatment for patients who respond suboptimally to anti-VEGF
standard of care for treatment of diabetic macular edema (DME). The
Phase 2 KALAHARI study is a two-part, randomized, prospective,
multi-center study assessing multiple injections of THR-149 in DME
patients who have previously shown a suboptimal response to
anti-VEGF therapy. Part B follows Part A of the study, in which
three dose levels of THR-149 (0.005mg, 0.022mg and 0.13mg), were
each administered in three monthly IVT injections, were evaluated
in order to select the best dose for Part B of the study.
High-level Month 3 data from Part A of the
KALAHARI trial was first presented in October 2021 and demonstrated
that in the eight 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. A post-hoc analysis of an OCT (Optical
Coherence Tomography) biomarker assessment, was performed by the
masked central reading center in February 2022. The masked reading
center identified two subjects with abnormalities at baseline,
which could impact responsiveness to any medical 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 learnings from the Part A
data were incorporated into Part B through an amended study design.
More information can be found here: NCT04527107
About Oxurion
Oxurion (Euronext Brussels: OXUR) is a
biopharmaceutical company developing next generation standard of
care ophthalmic therapies, which are designed to improve and better
preserve vision in patients with retinal disorders including
diabetic macular edema (DME), the leading cause of vision loss in
working-age people. Oxurion intends to play an important role in
the treatment of retinal disorders, including the successful
development of THR-149, its novel therapeutic for the treatment of
DME. THR-149 is a potent plasma kallikrein inhibitor being
developed as a potential new standard of care for the up to 50% of
DME patients showing suboptimal response to anti-VEGF therapy.
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 any 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 16 75 13 10michael.dillen@oxurion.com |
USConway CommunicationsBeth Kurthbkurth@conwaycommsir.com
ICR WestwickeChristopher BrinzeyTel: +1 617 835
9304Chris.Brinzey@westwicke.com |
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