Galapagos provides further insights into the treatment of
ulcerative colitis at the European Crohn’s and Colitis Organization
(ECCO) annual congress
- Nine presentations demonstrate Galapagos’ commitment to
inflammation and the ulcerative colitis (UC) community
- Four new analyses from Phase 3 SELECTION and SELECTION long
term extension studies of Jyseleca® (filgotinib)
provide additional insights into the management of ulcerative
colitis (UC)
- Initial results from European real-world survey
investigating the disease burden, including residual disease
symptoms and quality of life
Mechelen, Belgium; 2 February 2022,
22.01 CET; Galapagos NV (Euronext & NASDAQ:
GLPG) will present data at the
European Crohn’s and Colitis Organization (ECCO) annual congress
taking place 16-19 February 2022. Nine oral and poster
presentations will be showcased, including
four new analyses from the phase 3 SELECTION and SELECTION long
term extension (LTE) studies. These are part of the clinical
program assessing the efficacy and safety of Jyseleca (filgotinib),
an oral, once-daily, JAK1 preferential inhibitor, for the treatment
of patients 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. In addition,
insights from patients participating in a European real-world
survey on the disease burden of UC will be
presented.
“At Galapagos, we believe taking a holistic
approach to the management of ulcerative colitis is incredibly
important and can make a real difference for people living with
this disease,” said Dr. Walid Abi-Saab, Chief Medical Officer,
Galapagos. “Our commitment to understanding what matters most for
patients with UC and finding ways to better treat this often
debilitating disease, is reflected in the wide range of new data we
are presenting at ECCO.”
The new analyses provide further evidence of the
efficacy and safety profile of filgotinib 200mg, when used in
appropriate patients for the treatment of UC:
- Holistic assessment of disease and reporting of subjective
measures alongside objective measures can be equally important in
setting treatment goals to improve outcomes in UC. In this novel
post-hoc analysis of the SELECTION program a combined composite
endpoint, including clinical, biological, health related quality of
life (HRQoL) remission and endoscopic improvements was assessed for
patients treated with filgotinib (100mg and 200mg) versus
placebo.
- In the SELECTION study, filgotinib 200mg was well tolerated and
efficacious at inducing and maintaining clinical remission versus
placebo in patients with ulcerative colitis1. This interim analysis
of SELECTION LTE assesses the efficacy and safety outcomes of
long-term treatment with filgotinib 200mg, up to 96 weeks.
- Long-term treatment regimens in UC can present challenges for
patients who may need to interrupt therapy for various reasons2. A
post-hoc analysis of the SELECTION and SELECTION LTE studies was
undertaken to evaluate the efficacy and safety of re-treatment with
filgotinib, following treatment interruption.
- There is a clinical need to understand the impact of treatment
in elderly patients, where there is a growing prevalence of
inflammatory bowel disease (IBD)3. This post-hoc analysis of data
from the SELECTION program evaluates the efficacy and safety of
filgotinib, stratified by age.
In addition to the clinical data, Galapagos will
present initial results from a European real-world survey
investigating the disease burden, including residual disease
symptoms and quality of life impairment in moderate to severe UC
patients in remission and not in remission.
Oral and poster
presentations
Abstract Title |
Authors |
Presentation Date/Time |
|
Exploring disease control by combining clinical, biological, and
health-related quality of life remission with endoscopic
improvements among Ulcerative Colitis patients treated with
filgotinib: A post-hoc analysis from the SELECTION trial |
Stefan Schreiber, Brian Feagan, Laurent Peyrin-Biroulet, Severine
Vermeire, Margaux Faes, Kristina Harris, Alessandra Oortwijn,
Patrick Daniele, Haridarshan Patel and Silvio Danese |
Oral presentation: OP07Date: 17 February
2022Session: Navigating the Oceans of IBD - Scientific Session 3:
Aiming high with treatment goals in IBD: The modern Icarus?Session
time: 16:00 – 17:20 CETPresentation time: 16:40 – 16:50 CET |
Efficacy and safety of filgotinib in patients with Ulcerative
Colitis stratified by age: Post hoc analysis of the phase 2b/3
SELECTION and SELECTION LTE studies |
Stefan Schreiber, Edward V Loftus Jr, Christian Maaser, Silvio
Danese, Christine Rudolph, Rob Jongen, Angela De Haas, Alessandra
Oortwijn and Séverine Vermeire |
Digital Oral presentation: DOP37Date: 17 February
2022Session: DOP Session 5: The Southern: Small molecules in
IBDSession time: 17:30 – 18:30 CETPresentation time: 17:30 – 17:36
CET |
Re-treatment with filgotinib in patients with Ulcerative Colitis
following treatment interruption: Analysis of the SELECTION and
SELECTION LTE studies |
Séverine Vermeire, Brian Feagan, Laurent Peyrin-Biroulet,
Alessandra Oortwijn, Margaux Faes, Angela de Haas and Gerhard
Rogler |
Poster: P517Date: 18 February 2022Session: Guided
poster sessionPoster discussion session: 12:30 – 13:30 CET |
Efficacy and safety outcomes of long-term treatment with filgotinib
200 mg among patients with Ulcerative Colitis: An interim analysis
of SELECTIONLTE |
Brian Feagan, Katsuyoshi Matsuoka, Gerhard Rogler, Margaux Faes,
Alessandra Oortwijn, Angela de Haas, Christine Rudolph, Haridarshan
Patel and Laurent Peyrin-Biroulet |
Poster: P491Date: 18 February 2022Session: Guided
poster sessionPoster discussion session: 12:30 – 13:30 CET |
Rates of clinical remission among patients with Ulcerative Colitis
from real-world clinical practice settings from Germany |
Bernd Bokemeyer, Nils Picker, Daniel Kromer, Ludger Rosin and
Haridarshan Patel |
Poster: P506Date: 18 February 2022Session: Guided
poster sessionPoster discussion session: 12:30 – 13:30 CET |
Indicators for inadequate response among patients with Ulcerative
Colitis treated with advanced therapies in German clinical
practice |
Bernd Bokemeyer, Nils Picker, Daniel Kromer, Ludger Rosin and
Haridarshan Patel |
Poster: P598Date: 18 February 2022Session: Guided
poster sessionPoster discussion session: 12:30 – 13:30 CET |
Indicators for inadequate response to advanced therapy in patients
with Ulcerative Colitis: results from a medical chart review in the
United Kingdom |
James Oliver Lindsay, Nils Picker, Daniel Kromer, Michael Smyth and
Haridarshan Patel |
Poster: P389Date: 18 February 2022Session: Guided
poster sessionPoster discussion session: 12:30 – 13:30 CET |
Insights from patients with Ulcerative Colitis on disease burden:
Findings from a real-world survey in Europe |
Johan Michael Burisch, Ailsa Hart, Alessandra Oortwijn, Javaria
Mona Khalid, Fritha Hennessy, Hannah Knight, Rachael Meadows,
Haridarshan Patel and Alessandro Armuzzi |
Poster: P293Date: 18 February 2022Session: Guided
poster sessionPoster discussion session: 12:30 – 13:30 CET |
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 people4 are
affected by IBD, which includes UC and Crohn’s Disease (CD). UC is
a chronic inflammatory condition characterized by periods of flare
ups followed by 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 UC1. 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 (n=1348) had a Mayo Clinic Score (MCS) score of
9 or higher at baseline, and 43% of biologic experienced patients
(n=297/689) had insufficient response to a TNF antagonist and
vedoluzimab as well.
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).
Filgotinib is also approved and marketed as Jyseleca (200mg and
100mg tablets) in the European Union and Great Britain for the
treatment of adult patients with moderately to severely active UC
who have had an inadequate response with, lost response to, or were
intolerant to either conventional therapy or a biologic agent. An
application has been submitted to the Japan’s Pharmaceuticals and
Medical Devices Agency (PMDA) for the treatment of adults with
moderately to severely active UC and is currently under review. The
European Summary of Product Characteristics for filgotinib, which
includes contraindications and special warnings and precautions, is
available at www.ema.europa.eu. The Great Britain Summary of
Product Characteristics for filgotinib can be found at
www.medicines.org.uk/emc and the Northern Ireland Summary of
Product Characteristics for filgotinib can be found at
www.emcmedicines.com/en-GB/northernireland. The interview form from
the Japanese Ministry of Health, Labour and Welfare is available at
www.info.pmda.go.jp. A global Phase 3 program with filgotinib is
ongoing in Crohn’s Disease. More information about clinical trials
can be accessed at https://www.clinicaltrials.gov.
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 is responsible for the commercialization of
filgotinib in Europe, while Gilead will remain responsible for
filgotinib outside of Europe, including in Japan, where filgotinib
is co-marketed with Eisai.
About GalapagosGalapagos 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.
1. Feagan BF et al. Lancet (2021); 397:2372–84.2. Rubin DT.
Gastroenterol Hepatol (2019); 15 :612-53. Zammarchi et al. BMG
Gastroneterol (2020); 20 :1474. Burisch J. et al. Journal of
Crohn’s and Colitis (2013); 7:322-337
ContactInvestors: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
Marieke VermeerschHead of Corporate
Communication+32 479 490 603communications@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 and the SELECTION Phase 3 trial, 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 may not support registration or
further development of filgotinib due to
safety or efficacy concerns or other
reasons), the timing or likelihood of regulatory authorities
approval of marketing authorization for filgotinib for 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 our collaboration
partner for filgotinib, Gilead) and that Galapagos’
estimations regarding its filgotinib development program,
regarding the commercial potential
of filgotinib and regarding the out roll in
Europe may be incorrect 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.
- ECCO 2022 Curtain Raiser_vFinal_ENG
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