New Phase 2 studies with filgotinib in small bowel and fistulizing Crohn's disease
(Thomson Reuters ONE) -
Mechelen, Belgium; 10 March 2017 - Galapagos NV (Euronext & NASDAQ: GLPG)
announces two new Phase 2 studies investigating filgotinib in small bowel
Crohn's disease as well as in fistulizing Crohn's disease. These studies are
being led by filgotinib collaboration partner Gilead Sciences, Inc.
The first additional Crohn's disease Phase 2 study is a multi-center,
randomized, double-blind, placebo-controlled study to assess the safety and
efficacy of the investigational selective JAK1 inhibitor filgotinib in adult
patients with small bowel Crohn's disease. Approximately 100 patients in North
America and Europe are planned to be randomized in the study to receive one of
two doses of filgotinib or placebo, administered for 24 weeks. The primary
objective will be to compare filgotinib to placebo in establishing clinical
remission, defined as CDAI<150, in patients with small bowel Crohn's disease at
week 24.
The second Phase 2 study is a multi-center, randomized, double-blind, placebo-
controlled study to assess the safety and efficacy of the selective JAK1
inhibitor filgotinib in adult patients with perianal fistulizing Crohn's
disease. Approximately 75 patients are planned to be randomized in the study to
receive one of two doses of filgotinib or placebo administered for 24 weeks. The
primary objective is to evaluate the efficacy of filgotinib, compared to
placebo, in establishing a combined fistula response at week 24.
Eligible patients who complete either study may be able to continue in a long
term extension study.
These new Phase 2 studies with filgotinib follow the initiation of the DIVERSITY
Phase 3 study in Crohn's disease. Gilead further initiated the FINCH Phase 3
program in rheumatoid arthritis and the SELECTION Phase 2b/3 study in ulcerative
colitis in 2016.
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 small bowel Crohn's disease (SBCD)
Crohn's disease causes chronic inflammation and erosion of the intestines. It
can affect different regions of GI tract including the stomach and small and
large intestines. While isolated SBCD is an uncommon presentation of CD,
involvement of some portion of the small bowel (SB), particularly the ileum, is
common. Precise estimates of SB involvement vary in the literature, but
generally, some involvement occurs in up to 70% of patients, with isolated SB
disease reported in up to a third of patients {Hall 2015}. Patients with SBCD
experience cramps, diarrhea, abdominal discomfort (sometimes severe) and
fistulae.[1] While there is no therapy approved for SBCD specifically, current
treatment involves anti-tumor necrosis factor antibodies and other biologics.
About perianal fistulizing Crohn's disease
Fistulae are inflammatory tracts that most often occur between the distal colon
and the perianal region. Fistulae are one of the most severe sequelae of luminal
CD and the lifetime risk of occurrence is close to 50% of those with active CD.
Fistulizing CD may also cause painful abscesses in the abdomen. In acute
fistulizing perianal CD, the lesions represent manifestations of severe disease
activity and are concomitantly managed with medications that treat underlying
luminal disease (e.g., anti-TNF antibodies). Fistulae may progress to
destruction of the sphincter apparatus necessitating proctectomy after years of
continual inflammation and tissue erosion. Despite use of available therapies,
long term or durable remission rates for fistulizing CD are still low at
approximately 20%.
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.
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[1] From http://www.healthline.com/health/crohns-disease/types#TheFiveTypes2
New Phase 2 studies with filgotinib in CD:
http://hugin.info/133350/R/2086732/787384.pdf
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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: 10.03.2017 - 07:30 Uhr
Sprache: Deutsch
News-ID 529408
Anzahl Zeichen: 9117
contact information:
Town:
Mechelen
Kategorie:
Business News
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