Galapagos announces new Phase 2 Proof-of-Concept study with filgotinib in cutaneous lupus erythematosus
(Thomson Reuters ONE) -
Mechelen, Belgium; 25 April 2017, 22.00 CET - Galapagos NV (Euronext & NASDAQ:
GLPG) announces a new Phase 2 Proof-of-Concept study investigating filgotinib
and another investigational agent in cutaneous lupus erythematosus (CLE). This
study is being led by filgotinib collaboration partner Gilead Sciences, Inc.
"We are very excited with the initiation of this Proof-of-Concept study with
filgotinib in CLE. This is the first time we evaluate filgotinib in an
autoimmune skin disorder, and specifically, one with a significant unmet need,"
said Dr. Walid Abi-Saab, Chief Medical Officer of Galapagos. "This study
represents another cornerstone in Gilead and Galapagos' efforts to explore
filgotinib in inflammation. We look forward to seeing whether filgotinib can
impact signs and symptoms of CLE."
Galapagos and Gilead entered into a global collaboration for the development and
commercialization of filgotinib in inflammatory indications. This study in CLE
is in addition to the ongoing Phase 2 studies in Sjögren's syndrome, ankylosing
spondylitis (TORTUGA), and psoriatic arthritis (EQUATOR), as well as the ongoing
FINCH Phase 3 program in rheumatoid arthritis, the DIVERSITY Phase 3 study in
Crohn's disease (also Phase 2 in small bowel and fistulizing Crohn's disease),
and the SELECTION 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
Filgotinib in CLE
The Phase 2 study will be a multi-center, randomized, double-blind, placebo-
controlled study in adult female patients with active CLE. Approximately 50
patients are planned to be randomized in 18 centers in the US and Canada to
receive either filgotinib, another investigational drug or placebo, administered
once daily. The primary endpoint will be change the change from baseline in
Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity
score at Week 12.
About CLE
Lupus is an autoimmune disease affecting multiple organs and systems in the
body, resulting in a wide variety of signs and symptoms. CLE is a form of lupus
in the skin which can be triggered or exacerbated by exposure to sunlight. CLE
is most commonly diagnosed in women 20-50 years of age, although it may occur at
any age. Approximately 1/3 of women who are diagnosed with CLE also develop
systemic lupus erythematosus (SLE). Overall, therapeutic options for CLE are
limited, and there are limited clinical trial data in CLE for the biologic and
synthetic DMARDs that have been approved for other indications.
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 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 510 employees, operating from its
Mechelen, Belgium headquarters and facilities in The Netherlands, France, and
Croatia. More information at www.glpg.com.
Contacts
Investors: Media:
Elizabeth Goodwin Evelyn Fox
VP IR & Corporate Director Communications
Communications +31 6 53 591 999
+1 781 460 1784 communications(at)glpg.com
Paul van der Horst
Director IR & Business Development
+31 6 53 725 199
ir(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.
GLPG filgotinib in CLE:
http://hugin.info/133350/R/2098773/795038.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: 25.04.2017 - 22:00 Uhr
Sprache: Deutsch
News-ID 538310
Anzahl Zeichen: 7889
contact information:
Town:
Mechelen
Kategorie:
Business News
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