FITZROY Phase 2 study with filgotinib in Crohn's Disease presented as late breaker at DDW 2016
(Thomson Reuters ONE) -
Mechelen, Belgium; 25 May 2016, 22.00 CET: Galapagos (Euronext & NASDAQ: GLPG)
announces the presentation of detailed results from the Phase 2 FITZROY study of
filgotinib in Crohn's Disease, at Digestive Disease Week (DDW[1]) 2016 in San
Diego, CA, USA, held from 21-24 May. More information can be found at
www.ddw.org.
Prof. Dr. Séverine Vermeire, the principal investigator of the FITZROY study,
presented the results from this 174-patient study, initially reported in
December 2015. Galapagos reported that the study achieved the primary endpoint
of clinical remission: the percentage of patients achieving a Crohn's Disease
Activity Index (CDAI) score lower than 150 was statistically significantly
higher in patients treated with filgotinib versus patients receiving placebo.
The oral presentation, "Filgotinib (GLPG0634), an oral JAK1 selective inhibitor,
induces clinical remission in patients with moderate-to-severe Crohn's disease:
results from the Phase 2 FITZROY study interim analysis," took place today,
during the Clinical science late-breaking abstracts plenary session, abstract
#2488299.
In this Phase 2 study, filgotinib also demonstrated improvement in quality of
life (IBDQ). The rate of treatment-emergent adverse events was similar between
the filgotinib and placebo arms. The results support further development of
filgotinib in inflammatory bowel disease (IBD).
The company also presented a poster entitled "The JAK1-selective inhibitor,
filgotinib, reverses the disease signature of colon mucosa in experimental
colitis." The authors reported filgotinib prevents the changes observed in
mucosal gene expression induced by colitis, and that several of these genes also
display changes in human IBD. This poster was presented in the session
"Cytokines, Signaling and Receptors" on 21 May, abstract #2442351, poster #
Sa1844.
As per DDW policy, Galapagos is prohibited from distributing the presentation
and poster. Please contact the DDW organization (www.ddw.org) to receive a copy.
Galapagos did not provide financial support for the above scientific sessions
and did not influence the content in any way. However, research presented within
these scientific sessions were supported by Galapagos.
Galapagos and Gilead entered into a global collaboration agreement for the
global development and commercialization of filgotinib in inflammatory diseases.
The agreement became effective on January 19, 2016. Under the terms of the
agreement, the companies will collaborate jointly on the global development of
filgotinib starting with the initiation of Phase 3 trials in rheumatoid
arthritis and Crohn's Disease and a Phase 2 trial in ulcerative colitis.
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 maturing pipeline comprises Phase 2, Phase 1, pre-
clinical and discovery studies 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 440 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 the promising nature of the results with filgotinib, the potential
implications of these results for the future risk-benefit profile of filgotinib
and the expected timing of future Phase 3 clinical trials with filgotinib.
Galapagos cautions the reader that forward-looking statements are not guarantees
of future performance. In particular, it should be noted that the positive
interim results of the Phase 2 FITZROY study with filgotinib in Crohn's disease
may not be indicative of future results. 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 in rheumatoid arthritis, Crohn's disease and/or ulcerative
colitis 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] The name, logo and acronym of Digestive Disease Week(®) are the exclusive
property of and are trademarked by DDW LLC.
FITZROY Ph2 study in CD late breaker at DDW :
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Unternehmensinformation / Kurzprofil:
Datum: 25.05.2016 - 22:00 Uhr
Sprache: Deutsch
News-ID 473741
Anzahl Zeichen: 8555
contact information:
Town:
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Kategorie:
Business News
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