New Phase 2 study with filgotinib in non-infectious uveitis
July 05 2017 - 1:31AM
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.govFor more
information about filgotinib:
www.glpg.com/filgotinib
About GalapagosGalapagos (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.
ContactInvestors:Elizabeth GoodwinVP IR &
Corporate Communications +1 781 460 1784
Paul van der HorstDirector IR & Business Development +31 6
53 725 199ir@glpg.com
Media:Evelyn FoxDirector Communications +31 6 53 591 999
communications@glpg.com
Forward-Looking StatementsThis 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.
Attachments:
http://www.globenewswire.com/NewsRoom/AttachmentNg/3edfda36-425d-41bc-a7bc-c0336c78d355
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