Start Phase 2b/3 study with filgotinib in ulcerative colitis
December 08 2016 - 3:03PM
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.govFor more information about
filgotinib: www.glpg.com/filgotinib
About GalapagosGalapagos (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
& CorporateCommunications+1 781 460 1784 |
Director
Communications +31 6 53 591 999 communications@glpg.com |
Paul van
der HorstDirector IR & BusinessDevelopment+31 6 53 725 199 |
|
ir@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 StatementsThis 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.
Attachments:
http://www.globenewswire.com/NewsRoom/AttachmentNg/04fb9a22-fe3b-4920-8c2f-30695554f635
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