New Phase 2 study with filgotinib in non-infectious uveitis
July 05 2017 - 1:30AM
Mechelen,
Belgium; 5 July 2017; 7.30 CET - Galapagos NV (Euronext
& NASDAQ: GLPG) announces a new Phase 2 study investigating
filgotinib in non-infectious uveitis, being led by filgotinib
collaboration partner Gilead Sciences, Inc.
"We are pleased with the
initiation of this new Phase 2 study with filgotinib," said Dr.
Walid Abi-Saab, Chief Medical Officer of Galapagos. "We look
forward to seeing the study results which will show whether
filgotinib has the potential to impact signs and symptoms of
non-infectious uveitis, a group of inflammatory diseases carrying
significant visual morbidities."
The Phase 2 study will be a
multi-center, randomized, double-masked, placebo-controlled study
to assess the safety and efficacy of filgotinib in adult patients
with active, non-infectious uveitis. Approximately 110 patients are
planned to be randomized in the study to receive filgotinib or
placebo administered for 52 weeks. The primary goal is to evaluate
the efficacy and safety of filgotinib versus placebo for the
treatment of non-infectious intermediate-, posterior- or
pan-uveitis. The primary outcome is measured by the proportion of
subjects failing treatment by week 24; treatment failure is
representative of an active uveitis flare.
Galapagos and Gilead entered into
a global collaboration for the development and commercialization of
filgotinib in inflammatory indications. This study is an addition
to the ongoing Phase 2 studies in cutaneous lupus erythematosus,
Sjögren's syndrome, ankylosing spondylitis and psoriatic arthritis,
as well as the ongoing Phase 3 program in rheumatoid arthritis, the
Phase 3 study in Crohn's disease (also Phase 2 in small bowel and
fistulizing Crohn's disease), and Phase 2b/3 study in ulcerative
colitis.
Filgotinib is an investigational
drug and its efficacy and safety have not been
established.
For information about the studies with filgotinib:
www.clinicaltrials.gov
For more information about filgotinib:
www.glpg.com/filgotinib
About Galapagos
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage
biotechnology company specialized in the discovery and development
of small molecule medicines with novel modes of action. Our
pipeline comprises a pipeline of Phase 3, Phase 2, Phase 1,
pre-clinical, and discovery programs in cystic fibrosis,
inflammation, fibrosis, osteoarthritis and other indications. We
have discovered and developed filgotinib: in collaboration with
Gilead we aim to bring this JAK1-selective inhibitor for
inflammatory indications to patients all over the world. Galapagos
is focused on the development and commercialization of novel
medicines that will improve people's lives. The Galapagos group,
including fee-for-service subsidiary Fidelta, has approximately 530
employees, operating from its Mechelen, Belgium headquarters and
facilities in The Netherlands, France, and Croatia. More
information at www.glpg.com.
Contact
Investors:
Elizabeth Goodwin
VP IR & Corporate Communications
+1 781 460 1784
Paul van der Horst
Director IR & Business Development
+31 6 53 725 199
ir@glpg.com
Media:
Evelyn Fox
Director Communications
+31 6 53 591 999
communications@glpg.com
Forward-Looking
Statements
This release may contain forward-looking
statements, including statements regarding Galapagos' strategic
ambitions, the anticipated timing of clinical studies with
filgotinib and the progression and results of such studies.
Galapagos cautions the reader that forward-looking statements are
not guarantees of future performance. Forward-looking statements
involve known and unknown risks, uncertainties and other factors
which might cause the actual results, financial condition and
liquidity, performance or achievements of Galapagos, or industry
results, to be materially different from any historic or future
results, financial conditions and liquidity, performance or
achievements expressed or implied by such forward-looking
statements. In addition, even if Galapagos' results, performance,
financial condition and liquidity, and the development of the
industry in which it operates are consistent with such
forward-looking statements, they may not be predictive of results
or developments in future periods. Among the factors that may
result in differences are the inherent uncertainties associated
with competitive developments, clinical trial and product
development activities and regulatory approval requirements
(including that data from the ongoing and planned clinical research
programs may not support registration or further development of
filgotinib due to safety, efficacy or other reasons), Galapagos'
reliance on collaborations with third parties (including its
collaboration partner for filgotinib, Gilead), and estimating the
commercial potential of Galapagos' product candidates. A further
list and description of these risks, uncertainties and other risks
can be found in Galapagos' Securities and Exchange Commission (SEC)
filings and reports, including in Galapagos'
most recent annual report on form 20-F filed with the SEC and
subsequent filings and reports filed by Galapagos with the SEC.
Given these uncertainties, the reader is advised not to place any
undue reliance on such forward-looking statements. These
forward-looking statements speak only as of the date of publication
of this document. Galapagos expressly disclaims any obligation to
update any such forward-looking statements in this document to
reflect any change in its expectations with regard thereto or any
change in events, conditions or circumstances on which any such
statement is based or that may affect the likelihood that actual
results will differ from those set forth in the forward-looking
statements, unless specifically required by law or
regulation.
Filgotinib Phase 2
uveitis
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Galapagos NV via Globenewswire
Galapagos NV (NASDAQ:GLPG)
Historical Stock Chart
From Aug 2024 to Sep 2024
Galapagos NV (NASDAQ:GLPG)
Historical Stock Chart
From Sep 2023 to Sep 2024