Start Phase 2b/3 study with filgotinib in ulcerative colitis
December 08 2016 - 4:00PM
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
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 |
|
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
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
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