Start Phase 2b/3 study with filgotinib in ulcerative colitis
(Thomson Reuters ONE) -
First patient dosed triggers a $10 million milestone payment
Mechelen, Belgium; 8 December 2016 - Galapagos NV (Euronext & NASDAQ: GLPG)
reports the first dosing of a patient in the SELECTION Phase 2b/3 study with
filgotinib in ulcerative colitis. The start of the SELECTION study triggers a
$10 million milestone payment from Gilead.
The worldwide SELECTION Phase 2b/3 study will investigate efficacy and safety of
100 mg and 200 mg filgotinib once-daily compared to placebo in 1,300 patients
with moderately to severely active disease, including those with prior
biological therapy failure. The DIVERSITY Phase 3 study in Crohn's disease with
filgotinib started in November.
"Our collaboration partner Gilead is definitely keeping up the speed in rolling
out studies with filgotinib," said Piet Wigerinck, CSO of Galapagos. "We look
forward to seeing the results of both the DIVERSITY and SELECTION studies in
inflammatory bowel disease."
Galapagos and Gilead entered into a global collaboration for the development and
commercialization of filgotinib in inflammatory indications. In addition to the
DIVERSITY and SELECTION studies, Gilead initiated the FINCH Phase 3 program in
rheumatoid arthritis in August 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 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 a pipeline of 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 480 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
This press release contains inside information within the meaning of Regulation
(EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014
on market abuse (market abuse regulation).
Forward-Looking Statements
This release may contain forward-looking statements, including statements
regarding any guidance given by Galapagos' management, 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 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.
Start Phase 2b/3 study filgotinib in UC:
http://hugin.info/133350/R/2063174/774170.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
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: 08.12.2016 - 22:00 Uhr
Sprache: Deutsch
News-ID 511845
Anzahl Zeichen: 6767
contact information:
Town:
Mechelen
Kategorie:
Business News
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"Start Phase 2b/3 study with filgotinib in ulcerative colitis"
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