New Phase 2 study with filgotinib in non-infectious uveitis
(Thomson Reuters ONE) -
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(at)glpg.com
Media:
Evelyn Fox
Director Communications
+31 6 53 591 999
communications(at)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:
http://hugin.info/133350/R/2118055/806449.pdf
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
Unternehmensinformation / Kurzprofil:
Datum: 05.07.2017 - 07:30 Uhr
Sprache: Deutsch
News-ID 551038
Anzahl Zeichen: 6991
contact information:
Town:
Mechelen
Kategorie:
Business News
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