Galapagos presents new data from the SELECTION Phase 3 program at
the United European Gastroenterology Week (UEGW) 2021 congress
- Continuing filgotinib 200mg among induction non-responders at
week 10 resulted in clinical benefits for ulcerative colitis (UC)
patients in the long-term extension study (LTE)
- Treatment with filgotinib 200mg resulted in clinically
meaningful improvements in health-related quality of life (HRQoL)
measures by week 58 among patients with UC
Mechelen, Belgium; 4
October 2021, 22.01
CET; Galapagos NV (Euronext & NASDAQ:
GLPG) today
announced results
of two post-hoc
analyses from the SELECTION
and SELECTION LTE
studies, which
are part of the investigational clinical
program for filgotinib,
for the treatment of
patients with moderately to severely
active UC. These
analyses showed
clinical benefits of
continued dosing with filgotinib
200mg, an oral once-daily JAK1
preferential inhibitor, in
patients who did not respond at week 10.
Separately,
HRQoL benefits of
filgotinib 200mg treatment
versus placebo, in
patients with UC were
shown. These
data will be
presented at the
UEGW virtual 2021
congress (3 – 5
October).
In SELECTION, patients who did not respond to
induction therapy at week 10 could receive open-label filgotinib in
the LTE. In a post-hoc analysis, it was shown that continuing
filgotinib 200mg among those non-responders resulted in 65.7%
biologic-naïve and 62.2% biologic-experienced patients achieving
partial Mayo Clinic Score (pMCS) response by Week 12, with 17.1%
biologic-naïve and 16.7% biologic-experienced patients in pMCS
remission (Presentation MP082).1
A post-hoc analysis of HRQoL data from the
SELECTION study shows that patients treated with filgotinib 200mg
achieved clinically meaningful improvements in their quality of
life, versus placebo. These included Inflammatory Bowel Disease
Questionnaire remission and measurements of productivity, physical,
and mental components, assessed by 36-item Short Form Survey
(SF-36), EuroQol 5-dimension (EQ-5D) visual analogue scale and Work
Productivity and Activity Impairment questionnaire (Poster
PO457).2
Dr Walid Abi-Saab, Chief Medical officer, at
Galapagos said, “The SELECTION study has provided us with a wealth
of data on the efficacy and safety profile of filgotinib that, if
approved can potentially inform clinical treatment approaches. This
includes findings on the benefits of prolonged dosing with
filgotinib 200mg among induction non-responders and the achievement
of treatment goals beyond clinical symptoms of UC. We know that
patients with UC are impacted by this disease physically, socially
and psychologically, which is why inclusion of health-related
quality of life measures in our clinical trials is so important to
build a holistic understanding of the management of the
disease.”
These data were in two of thirteen abstracts
from the company relating to filgotinib in the treatment of
patients with UC. The use of filgotinib for the treatment of UC is
investigational and is not approved anywhere
globally. Key Filgotinib Abstracts:
Abstract Title |
Lead Author |
Poster number and time and date |
Benefit of prolonged filgotinib dosing in patients with ulcerative
colitis who did not respond to induction therapy: data from the
SELECTION long-term extension study |
Séverine Vermeire |
Moderated poster
presentation
- Presentation number: MP082
- Session: IBD: Clinical trials poster II
- Date: Monday 4 October 2021, 13:30–14:30 CET
|
Clinically meaningful improvements in health-related quality of
life among patients with ulcerative colitis treated with filgotinib
– a post hoc analysis of SELECTION |
William J Sandborn |
Poster presentation
- Presentation number: P0457
- Poster Session: IBD
- Date: Sunday 3 – Tuesday 5 October
|
A Matching-Adjusted Indirect Comparison of Maintenance Oral
Filgotinib versus Intravenous Vedolizumab for Moderately to
Severely Active Ulcerative Colitis |
Xiaoyan Lu |
Poster presentation
- Presentation number: P0489
- Poster Session: IBD
- Date: Sunday 3 – Tuesday 5 October
|
Efficacy of filgotinib in patients with ulcerative colitis by line
of therapy in the phase 2b/3 SELECTION trial |
Laurent Peyrin-Biroulet |
Oral presentation
- Presentation number: OP191
- Session: IBD clinical trials IV
- Session Type: Live Abstract-based Session
- Date: Tuesday 5 October 2021 13:30–14:30 CEST
|
Relationship between histo-endoscopic mucosal healing and baseline
characteristics in patients with moderately to severely active
ulcerative colitis receiving filgotinib in the phase 2b/3 SELECTION
study |
Laurent Peyrin-Biroulet |
Poster presentation
- Presentation number: P0427
- Poster session: IBD
- Date: Sunday 3 – Tuesday 5 October
|
About Ulcerative
Colitis Ulcerative colitis (UC) is a
debilitating inflammatory bowel disease (IBD) that occurs as a
result of an abnormal immune system response. Across Europe an
estimated 2.5 - 3 million people3 are affected by IBD,
which includes UC and Crohn’s Disease (CD). UC is a chronic
inflammatory condition of the gastrointestinal (GI) tract. The
disease course of UC is often a state of flare ups and ensuing
periods of remission. In addition to the physical impact from flare
ups, there is also a psychological impact associated with UC. It
causes significant impairments on quality of life and a poor
prognosis is often seen in patients with symptoms of moderate to
severe UC at diagnosis.
About the SELECTION Phase 3
TrialThe SELECTION Phase 3 trial is a multi-center,
randomized, double-blind, placebo-controlled trial to assess the
safety and efficacy of the preferential JAK1 inhibitor filgotinib
in adult patients with moderately to severely active UC. The
SELECTION trial comprises two induction trials and a maintenance
trial. The Induction Study A enrolled biologic-naïve patients, and
the Induction Study B enrolled biologic-experienced patients.
The primary objectives of SELECTION were to
evaluate the efficacy of filgotinib compared with placebo in
establishing clinical remission as determined by the Mayo
endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, and ≥
1-point decrease in stool frequency from baseline to achieve a
subscore of 0 or 1 at Week 10 in the induction studies and Week 58
in the maintenance study. Eligible patients who were enrolled in
the SELECTION trial were enrolled in the ongoing SELECTION
long-term extension trial to evaluate the long-term safety of
filgotinib in patients with UC. A majority of patients included in
the SELECTION trial had a MCS score of 9 or higher at baseline, and
43% of biologic experienced patients had insufficient response to a
TNF antagonist and vedoluzimab as well.
About HRQoL
and IBDQHealth-related quality of life (HRQoL) is
a concept that measures physical, emotional, mental, and social
impact of the disease on patients’ lives. The instruments used to
measure HRQoL were a 36-item Short Form Survey (SF-36), EuroQol
5-dimension visual analogue scale (EQ-5D-VAS) and Work,
Productivity and Activity Impairment (WPAI) questionnaire, and
Inflammatory Bowel Disease Questionnaire (IBDQ).
The IBDQ is a questionnaire for health-related
quality of life assessment in patients with inflammatory bowel
diseases: ulcerative colitis and Crohn’s disease. It consists of 32
questions divided into four groups: bowel symptoms (10 items),
systemic symptoms (5 items), emotional function (12 items) and
social function (5 items). Every question has graded responses from
1 to 7, and thus the total score can range from 32 to 224 with
higher scores representing better health-related quality of life.
IBDQ remission was defined by an IBQ total score ≥170 points. The
IBDQ is a validated assessment tool that reflects important changes
in the quality of life of patients with IBD (adapted from Pallis et
al, Inflamm Bowel Dis, Volume 10, Number 3, May 2004).
SF-36 is a generic health-assessment
questionnaire that is utilized in clinical trials to study the
impact of chronic disease on health-related quality of life.
EQ-5D is a general, non–disease-specific
health-related quality-of-life questionnaire.
WPAI is a tool used to measure the impact of a
disease on work and on daily activities.
About filgotinibFilgotinib is
approved and marketed as Jyseleca® (200mg and 100mg tablets) in the
European Union, Great Britain, and Japan for the treatment of
adults with moderate to severe active rheumatoid arthritis (RA) who
have responded inadequately or are intolerant to one or more
disease modifying anti-rheumatic drugs (DMARDs). Filgotinib may be
used as monotherapy or in combination with methotrexate (MTX). The
European Summary of Product Characteristics for filgotinib, which
includes contraindications and special warnings and precautions, is
available at www.ema.europa.eu. The interview form from the
Japanese Ministry of Health, Labour and Welfare is available at
www.info.pmda.go.jp. The individual Great Britain and Northern
Ireland Summary of Product Characteristics can be found at
www.medicines.org.uk/emc and
www.emcmedicines.com/en-GB/northernireland respectively.
Applications have been submitted to the European Medicines Agency
(EMA), the UK’s Medicines and Healthcare products Regulatory Agency
(MHRA), and Japan’s Pharmaceuticals and Medical Devices Agency
(PMDA) for the treatment of adults with moderately to severely
active ulcerative colitis (UC) who have had an inadequate response
with, lost response to, or were intolerant to either conventional
therapy or a biologic agent and are currently under review. A
positive opinion was recommended for this UC indication by the
EMA’s Committee for Medicinal Products for Human Use (CHMP) on 17th
September. Filgotinib is not approved in any other countries.
Jyseleca® is a trademark of Galapagos NV and
Gilead Sciences, Inc. or its related companies.
About the filgotinib
collaborationGilead and Galapagos NV are collaborative
partners in the global development and commercialization of
filgotinib. Galapagos will be responsible for the commercialization
of filgotinib in Europe (transition anticipated to be completed by
end of 2021), while Gilead will remain responsible for filgotinib
outside of Europe, including in Japan, where filgotinib is
co-marketed with Eisai. Filgotinib in UC has been filed in the
European Union, Great-Britain and Japan, and a global Phase 3
program is ongoing in Crohn’s Disease. More information about
clinical trials can be accessed at
https://www.clinicaltrials.gov.
About Galapagos Galapagos NV
discovers, develops, and commercializes small molecule medicines
with novel modes of action. Our pipeline comprises discovery
through Phase 3 programs in inflammation, fibrosis, and other
indications. Our ambition is to become a leading global
biopharmaceutical company focused on the discovery, development,
and commercialization of innovative medicines. More information at
www.glpg.com.
- Vermeire, S, et al. Benefit of prolonged filgotinib dosing in
patients with ulcerative colitis who did not respond to induction
therapy: data from the SELECTION long-term extension study: post
hoc analysis of the phase 2b/3 SELECTION study MP082, UEGW Congress
2021
- Sandborn. W, et al. Clinically meaningful improvements in
health-related quality of life among patients with ulcerative
colitis treated with filgotinib: post hoc analysis of the phase
2b/3 SELECTION study. P0457, UEGW Congress 2021
- Burisch J. et al. The burden of inflammatory bowel disease in
Europe. Journal of Crohn’s and Colitis (2013) 7, 322-337
Contacts
Investors:Elizabeth GoodwinVP
Investor Relations +1 781 460 1784
Sofie Van GijselSenior Director Investor Relations+1 781 296
1143
Sandra CauwenberghsDirector Investor Relations+32 495 58 46
63ir@glpg.com
Media:Anna GibbinsSenior Director Therapeutic
Areas Communications+44 7717 801900
Evelyn FoxDirector Executive Communications +31 65 3591
999 communications@glpg.com
Forward Looking Statements
This press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995, as amended, that are subject to risks,
uncertainties and other factors that could cause actual results to
differ materially from those referred to in the forward-looking
statements and, therefore, the reader should not place undue
reliance on them. These risks, uncertainties and other factors
include, without limitation, the inherent risks associated with
clinical trial and product development activities, including the
filgotinib clinical program, competitive developments, and
regulatory approval requirements, including the risk that data from
the ongoing and planned clinical research programs with filgotinib
may not support registration or further development in UC or other
indications due to safety, efficacy or other reasons, the timing or
likelihood of regulatory authorities approval of marketing
authorization for filgotinib for UC or any other indications, such
regulatory authorities requiring additional studies, the risk that
Galapagos will not be able to continue to execute on its currently
contemplated business plan and/or will need to revise its business
plan, Galapagos’ reliance on collaborations with third parties,
including the collaboration with Gilead for filgotinib, the
uncertainty regarding estimates of the commercial potential of
filgotinib, the timing of and the risks related to the
implementation of the transition of the European commercialization
responsibility of filgotinib from Gilead to us, including the risk
that the transition will not be completed on the currently
contemplated timeline or at all, and the risk that the transition
will not have the currently expected results for our business and
results of operations; and, the uncertainties relating to the
impact of the COVID-19 pandemic on our strategy, business plans and
focus as well as those risks and uncertainties identified in our
Annual Report on Form 20-F for the year ended 31 December 2020 and
our subsequent filings with the SEC. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. The forward-looking statements
contained herein are based on management’s current expectations and
beliefs and speak only as of the date hereof, and Galapagos makes
no commitment to update or publicly release any revisions to
forward-looking statements in order to reflect new information or
subsequent events, circumstances or changes in expectations.
- UEGW data_press release 2021_v_ENG_FINAL
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