Oxurion NV announces full enrollment of its Phase 2 trial evaluating efficacy and safety of the combination of anti-PlGF (THR...
04 Abril 2019 - 11:30PM
Leuven, Belgium,
April 4th 2019 -
Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company
developing innovative treatments to preserve vision in patients
with diabetic eye disease, announces today that all patients have
been enrolled in its Phase 2 trial evaluating its THR-317, a
humanized antibody against placental growth factor (PlGF), in
combination with anti-VEGF (ranibizumab), an anti-vascular
endothelial growth factor (VEGF) antibody, for the treatment of
Diabetic Macular Edema (DME). A total of 70 patients were enrolled
in the study, ahead of schedule. Topline data from the study are
expected by Q3 2019.
The purpose of the proof of
concept study is to evaluate the safety and efficacy of 3 monthly
intravitreal injections of THR-317 and ranibizumab in subjects with
center-involved DME (CI-DME). The combination of ranibizumab and
sham is used as control. Patients will be followed up until 3
months after the last injection (NCT03499223).
Positive data from an earlier
Phase 1/ 2 study with THR-317 (mono), demonstrated the safety and
tolerability of THR-317 for intra-ocular use. Moreover, reported
Day 90 data indicated that 30% of anti-VEGF treatment naïve
patients (n=40) had a 3 line or more (>15 letters) gain in Best
Corrected Visual Acuity (BCVA) after 3 monthly injections with
THR-317 (8mg). Day 150 showed that 30% of the 8mg anti-VEGF
treatment naïve group still showed > 10 letters vision gain.
DME is the result of an
accumulation of fluid in the macula - the part of the retina that
controls detailed vision - due to leaking blood vessels. DME
represents an area of unmet medical need as the current standard of
care treatment with anti-VEGF has been shown to deliver suboptimal
results in a significant number of patients. It is believed
that simultaneously inhibiting VEGF (ranibizumab) and PlGF
(THR-317) could deliver incremental benefit over either treatment
alone.
Patrik De Haes,
M.D., CEO of Oxurion nv, comments:
"We are delighted to announce the earlier than
anticipated full enrollment of our Phase 2 study evaluating THR-317
in combination with ranibizumab for the treatment for DME. This
proof of concept clinical study will for the first time provide
important insights into the additional effect anti-PlGF (THR-317)
could provide on top of anti-VEGF therapy, the current standard of
care for treating DME patients."
END
For further
information please contact:
Oxurion
NV
Wouter Piepers,
Global Head of Investor Relations & Corporate
Communications
+32 16 75 13 10 / +32 478 33 56 32
wouter.piepers@oxurion.com
|
EU - Citigate Dewe Rogerson
David Dible/ Sylvie Berrebi
Tel: +44 20 7638 9571
oxurion@citigatedewerogerson.com |
US - LifeSci Public Relations
Alison Chen
+1 646-876-4932
achen@lifescipublicrelations.com
|
About Oxurion
Oxurion (Euronext Brussels: OXUR)
is a biopharmaceutical company currently developing a competitive
pipeline of disease-modifying drug candidates for diabetic eye
disease, a leading cause of blindness of people of working age
worldwide.
Oxurion's most advanced drug candidate is THR-317, a PlGF inhibitor
for the treatment of diabetic macular edema (DME), which is
currently in a Phase 2 study in combination with
Lucentis®. THR-317 is
also being evaluated in a Phase 2 study for the treatment of
Idiopathic Macular Telangiectasia Type 1 (MacTel 1), a rare retinal
disease that affects the macula and can lead to vision
loss.
Oxurion has two further pipeline candidates, THR-149, a plasma
kallikrein inhibitor being developed for the treatment of DME; and
THR-687, a pan-RGD integrin antagonist in development for the
treatment of diabetic retinopathy and DME. Both THR-149 and THR-687
are in Phase 1 clinical studies.
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.
This
announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Oxurion NV via Globenewswire
Thermon (NYSE:THR)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Thermon (NYSE:THR)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024