Galapagos announces new Phase 2 Proof-of-Concept study with filgotinib in cutaneous lupus erythematosus
April 25 2017 - 4:01PM
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.govFor more information about
filgotinib: www.glpg.com/filgotinib
Filgotinib in CLEThe 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 CLELupus 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 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 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
& CorporateCommunications+1 781 460 1784 |
Director
Communications +31 6 53 591 999 communications@glpg.com |
Paul van der
HorstDirector IR & Business Development+31 6 53 725 199 |
|
ir@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.
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