Results from 10-week analysis of Phase 2 study with filgotinib in Crohn's Disease presented at ECCO
March 18 2016 - 2:33AM
Galapagos (Euronext & NASDAQ: GLPG) announces the presentation
of detailed results from the Phase 2 FITZROY study of
filgotinib in Crohn's Disease, at the 11th Congress of ECCO in
Amsterdam, the Netherlands, from March 16 - 19.
Prof Dr Séverine Vermeire, the principal investigator of the
FITZROY study, will be presenting the results on the 10-week on
treatment analysis. These results from this 174-patient study
were reported in December 2015 and indicated 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 (48
percent (61/128) vs. 23 percent (10/44), p<0.05).
The presentation on 18 March, takes place at the Scientific
Session in ECCO Fellowship & Grants, at 15.50 - 16.00 hours
CET. Filgotinib is the first JAK inhibitor to show clinical
efficacy in moderate to severely active Crohn's Disease.
Furthermore, filgotinib showed improvement in quality of life
(IBDQ) in TNF-naive and TNF-failure populations. The rate of
treatment-emergent adverse events was similar between the
filgotinib and placebo arms; the most common adverse events
occurring in each study arm were infections and infestations (26
percent vs. 23 percent), gastrointestinal disorders (24 percent vs.
23 percent) and nervous system disorders (16 percent vs. 18
percent). The 10-week results support further development of
filgotinib in inflammatory bowel disease (IBD). Galapagos and
Gilead Sciences also expect to report the full 20-week results for
FITZROY in the first half of 2016.
In December 2015, Galapagos and Gilead signed a global
collaboration agreement for the global development and
commercialization of filgotinib in inflammatory diseases.
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.
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 three Phase 2, three
Phase 1, five pre-clinical, and 20 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.
Contact Galapagos NV
Investors: Media:
Elizabeth
Goodwin Evelyn
Fox VP IR & Corporate
Communications Director
Communications +1 781 460
1784
+31
6 53 591 999
ir@glpg.com
communications@glpg.com
Galapagos 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 Galapagos' ongoing clinical
research programs in rheumatoid arthritis and Crohn's disease may
not support registration or further development of filgotinib due
to safety, efficacy or other reasons), Galapagos' reliance on
collaborations with third parties, 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)
filing and reports, including in Galapagos' prospectus filed with
the SEC on 14 May 2015 and subsequent filings and reports filed by
the company 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.
Results 10-week FITZROY at ECCO
http://hugin.info/133350/R/1995789/735233.pdf
HUG#1995789
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