Phase 3 study with filgotinib initiated in Crohn's disease
November 22 2016 - 4:04PM
Galapagos NV (Euronext & NASDAQ: GLPG) reports the
first dosing of a patient in the DIVERSITY Phase 3 study with
filgotinib in Crohn's disease (CD). The start of the DIVERSITY
study triggers a $50 million milestone payment from
Gilead.
The worldwide DIVERSITY Phase 3 study will
investigate efficacy and safety of 100 mg and 200 mg filgotinib
once-daily compared to placebo in 1,320 patients with moderately to
severely active Crohn's disease, including those with prior
biological therapy failure.
"With the FITZROY Phase 2 study, Galapagos
demonstrated that filgotinib has a promising efficacy and safety
profile in Crohn's disease. The start of the Phase 3 DIVERSITY
study is good news for patients with Crohn's disease," said Dr Piet
Wigerinck, CSO of Galapagos. "We look forward to seeing the results
of DIVERSITY."
Galapagos and Gilead entered into a global
collaboration for the development and commercialization of
filgotinib in inflammatory indications. In addition to the
DIVERSITY study, Gilead initiated the FINCH Phase 3 program in
rheumatoid arthritis in August 2016 and is expected to start the
SELECTION Phase 2b/3 study in ulcerative colitis later this
quarter.
Filgotinib is an investigational drug and its
efficacy and safety have not been established.
For information about the studies with
filgotinib in IBD: 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.
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