Successful completion of regulatory consultations to progress filgotinib to Phase 3 in inflammatory bowel disease
September 27 2016 - 4:04PM
- Global program to start in Q4'16
- DIVERSITY Phase 3 study in Crohn's disease
- SELECTION Phase 2b/3 study in ulcerative colitis
- 100 mg and 200 mg once daily doses included
Galapagos NV (Euronext & NASDAQ: GLPG) reports the
successful completion of discussions with the regulatory
authorities in the US and Europe to initiate the DIVERSITY Phase 3
study in Crohn's disease and the SELECTION Phase 2b/3 study in
ulcerative colitis with filgotinib. Both studies will investigate
efficacy and safety of 100 mg and 200 mg filgotinib once-daily
compared to placebo in patients with moderately to severely active
disease including those with prior antibody therapy failure. First
dosing is expected in Q4'16.
Both studies will recruit approximately 1,300
patients each from the US, Europe, Latin America, Canada, and
Asia/Pacific. The SELECTION Phase 2b/3 study in ulcerative colitis
will include a futility analysis, serving as the Phase 2b part of
this integrated Phase 2b/3 study. Men and women in both the
SELECTION and DIVERSITY studies will be randomized to receive
placebo, 100 mg or 200 mg filgotinib. In the US, males may receive
200 mg if they failed at least one anti-TNF and vedolizumab[1]. The
filgotinib Phase 3 program will also contain a dedicated male
patient testicular safety study.
"The outcome of the discussions with US and
national European regulatory authorities enables our collaboration
partner Gilead to further evaluate filgotinib in IBD," said Dr Piet
Wigerinck, Chief Scientific Officer at Galapagos. "The improvements
in clinical signs, quality of life, and endoscopy in Crohn's
patients reported in the FITZROY Phase 2 study support this next
step."
Galapagos and Gilead entered into a global
collaboration for the development and commercialization of
filgotinib in inflammatory indications. Gilead initiated the FINCH
Phase 3 program in rheumatoid arthritis in August 2016.
Filgotinib is an investigational therapy 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 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 maturing 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 460
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, the
progression and results of such studies and ongoing interactions
with regulatory authorities. 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.
[1] Vedolizumab is a monoclonal anti-integrin
antibody developed by Millennium Pharmaceuticals.
Succesful completion of regulatory discussions filgotinib in IBD
http://hugin.info/133350/R/2045017/763762.pdf
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