MECHELEN, Belgium, May 25, 2016 (GLOBE NEWSWIRE) -- 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