FITZROY Phase 2 study with filgotinib in Crohn's Disease presented as late breaker at DDW 2016
May 25 2016 - 4:04PM
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 (DDW1)
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 Communications +1 781 460 1784 |
Director
Communications +31 6 53 591 999 communications@glpg.com |
Paul van der Horst Director IR & Business Development +31 6 53
725 199 |
|
ir@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.
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
http://hugin.info/133350/R/2015546/747317.pdf
HUG#2015546
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