Oxurion Announces Top-Line Results from Part A of Phase 2 INTEGRAL Trial Evaluating THR-687 for Treatment of Diabetic Macular Edema (DME)
09 Mayo 2022 - 1:30AM
Oxurion Announces Top-Line Results from Part A of Phase 2 INTEGRAL
Trial Evaluating THR-687 for Treatment of Diabetic Macular Edema
(DME)
Trial did not demonstrate efficacy on the key
clinical endpoints
Oxurion to focus on its Phase 2 development
program for THR-149
Leuven,
BELGIUM, Boston, MA, US
– MAY
9,
2022 –
8:30 AM 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 announces top-line results from Part A of its
Phase 2 trial (“INTEGRAL”) of THR-687, an integrin antagonist, for
the treatment of diabetic macular edema (DME). The Part A data
showed THR-687 to be safe and well tolerated with no serious
adverse events and none of the patients required rescue medication
through Month 3, however, there was insufficient evidence of
efficacy on the key endpoints (Best-Corrected Visual Acuity and
Central Subfield Thickness). As a result, Oxurion has decided not
to advance THR-687 to Part B of the INTEGRAL trial. The company is
therefore fully focused on THR-149 which recently demonstrated a
compelling safety and efficacy profile in patients with DME in the
first part of the two-part Phase 2 KALAHARI trial. Part B of that
trial is currently enrolling patients in the US and Europe. The
INTEGRAL trial is a two-part, randomized, prospective, multicenter
trial assessing multiple injections of THR-687 in treatment naïve
DME patients. The Part A endpoints were safety (n = 16) and
efficacy (n = 14), with two dose levels of THR-687 (1.2mg and
2.0mg) each administered in three monthly IVT injections. Patients
are being followed-up until month six of Part A of the trial, and
we look forward to presenting the full data set at an upcoming
medical conference.
Arshad M. Khanani, M.D., M.A., Director
of Clinical Research at Sierra Eye Associates, Reno, Nevada,
US, comments: "We are disappointed that the top-line
results in the dose selection phase of the INTEGRAL trial did not
meet the key efficacy endpoints, despite promising data in the
Phase 1 trial. Novel mechanisms, like THR-687 and THR-149, remain
an important opportunity to address the significant unmet medical
needs for our patients with DME. Following the impressive data
presented at Angiogenesis this year from the Phase 2 Part A
KALAHARI trial for THR-149 in DME, I am looking forward to seeing
the Part B data expected next year."
Tom Graney, CFA, Chief Executive Officer
of Oxurion, comments: “While we had hoped for a
better outcome for the patients in the INTEGRAL trial, we remain
committed to developing new treatments to address the substantial
unmet needs that remain in retinal diseases. We are excited about
the potential of THR-149, a potent plasma kallikrein inhibitor, to
provide a novel, first-in-class therapeutic for the up to 50% of
DME patients who suboptimally respond to the current standard of
care and have limited treatment options. We look forward to sharing
the topline results of Part B of the Phase 2 trial in mid-2023.” He
added, “As we discontinue our development of THR-687, we will
explore potential partnership opportunities for the asset.
Additionally, we are undertaking a thorough review of our capital
and resource allocation plans to ensure that they are aligned with
our objective of maximizing value creation for all
stakeholders.”
About
OxurionOxurion (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, as well as other conditions. 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 statementsCertain 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 more
information, please contact:
Oxurion NVTom GraneyChief Executive OfficerTel:
+32 16 75 13 10tom.graney@oxurion.com Michaël DillenChief
Business OfficerTel: +32 16 75 13 10michael.dillen@oxurion.com |
USConway Communications Beth
Kurth bkurth@conwaycommsir.com Westwicke, an
ICR CompanyChristopher BrinzeyTel: +1 617 835
9304chris.brinzey@westwicke.com |
- OXUR THR-687 Part A 2022.0509 Final
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