Galapagos to present new data from long-term extension study of
filgotinib in ulcerative colitis at annual ECCO congress 2023
- Six presentations demonstrate Galapagos’ commitment to the
inflammatory bowel disease (IBD) community
- New analyses from Phase 3 SELECTION and SELECTION long-term
extension (LTE) studies of Jyseleca® (filgotinib, an oral, once
daily, JAK1 preferential inhibitor) will be presented
- SELECTIONLTE showed that filgotinib maintained a consistent
safety profile; symptomatic remission rates and health-related
quality of life (HRQoL) improved in patients with moderate to
severe active ulcerative colitis (UC) who received filgotinib 200mg
for nearly four years
Mechelen,
Belgium; 27
February 2023, 22.01
CET; Galapagos NV (Euronext & NASDAQ:
GLPG) will present
new data at the European Crohn’s and
Colitis Organization (ECCO) annual congress taking place from 1-4
March 2023.
A number of abstracts will present analyses from
the SELECTION program with filgotinib. These include new analysis
from the long-term extension study evaluating the safety and
efficacy of filgotinib in UC for nearly four years; an analysis of
the prolonged benefit of filgotinib in UC; an analysis exploring
factors associated with the partial Mayo Clinic Score (pMCS) over
time; and analysis of the effect of filgotinib on anaemia in UC
patients.
Additionally, Galapagos will present pooled data
from five Phase 2/3 trials, and two long-term extension trials of
filgotinib designed to further understand the safety profile of
filgotinib in UC and rheumatoid arthritis (RA).
“We are excited to present data from multiple
studies of filgotinib in UC, including results from the
SELECTIONLTE study, which has been selected amongst the top 11 oral
abstracts at ECCO,” said Daniele D’Ambrosio, MD, PhD, Therapeutic
Area Head, of Immunology, at Galapagos. “These presentations
capture our broad range of research and commitment to the IBD
community and underscore our mission to improve patients’ lives by
targeting diseases with high unmet needs.”
Data from the SELECTIONLTE study showed that
filgotinib 200mg maintained symptomatic remission and HRQoL for up
to approximately four years. Amongst subjects who completed the
study, the reduction in mean pMCS in SELECTION was maintained up to
LTE Week 144. In non-responders, mean pMCS decreased from LTE
baseline to Week 192. The results also showed that a high
proportion of completers (>80% of patients) and non-responders
(>70% of patients) achieved remission according to the
Inflammatory Bowel Disease Questionnaire1.
The safety profile of filgotinib 200mg in the
SELECTIONLTE study was generally consistent with the safety profile
observed in previous SELECTION studies, with no new safety signals
observed.
“For healthcare professionals treating patients
with this debilitating disease, the results from the SELECTION
studies provide an understanding of filgotinib’s long-term outcomes
and help make the most appropriate choices for their patients,”
said Dr. Brian G. Feagan, MD, FRCPC, Professor of Medicine,
Epidemiology and Biostatistics, Western University, London,
Ontario, Canada and lead investigator of the SELECTION trial. “This
latest data reinforces the positive long-term safety and efficacy
profile of filgotinib, indicating its potential to be an important
treatment option for people living with moderate to severe UC.”
Galapagos is also hosting a hybrid symposium:
‘Journey to comprehensive disease control
in UC’ on Thursday 2 March 2023 from 18:45-19:45 CET,
which will feature experts’ perspectives on what matters most to
patients, and how to raise the bar when treating patients with UC.
The symposium will include a mix of classical plenary lectures,
including tackling challenges and misconceptions, sharing of
real-world practical experience in the management of patients with
UC, and the place of JAK inhibition in clinical practice.
Key Abstracts:
Abstract title |
Authors |
Presentation date/time |
Efficacy and safety outcomes up to ~4 years of treatment with
filgotinib 200mg among patients with Ulcerative Colitis: Results
from the SELECTION LTE study |
Brian Feagan, Katsuyoshi Matsuoka, Gerhard Rogler, Margaux Faes,
Alessandra Oortwijn, Angela de Haas, Christine Rudolph and Laurent
Peyrin-Biroulet |
Oral presentationPresentation
number: OP35Presentation date, time &
location: Saturday 4 March 2023, 09:50-10:00, Plenary
HallSession name: Sequencing in IBD -
Scientific Session 10: Evolving goals |
Prolonged benefit of filgotinib in patients with Ulcerative Colitis
in SELECTION |
David Laharie, Andreas Sturm, Taku Kobayashi, Takayuki Matsumoto,
Alessandra Oortwijn, Corinne Jamoul, Margaux Faes, Angela de Haas
and Séverine Vermeire |
Poster presentationPresentation
number: P690Presentation date, time &
location: Friday 3 March 2023, 12:30-13:30, Poster
Exhibition, Hall B5&6 |
Factors associated with partial Mayo Clinic Score over time in
patients with Ulcerative Colitis treated with filgotinib in the
phase 2b/3 SELECTION trial |
Laurent Peyrin-Biroulet, Edouard Louis, Tadakazu Hisamatsu, Corinne
Jamoul, Eva Santermans, Kristina Harris, Angela de Haas, Alessandra
Oortwijn and Brian Feagan |
Poster presentationPresentation
number: P736Presentation date, time &
location: Friday 3 March 2023, 12:30-13:30, Poster
Exhibition, Hall B5&6 |
Effect of filgotinib on anaemia in patients with Ulcerative Colitis
in SELECTION |
Roberta Loveikyte, Angela de Haas, Alessandra Oortwijn, Bart
Eskens, Corinne Jamoul, Karine Muller and Andrea E. van der
Meulen-de Jong |
Poster presentationPresentation
number: P393Presentation date, time &
location: Friday 3 March 2023, 12:30-13:30, Poster
Exhibition, Hall B5&6 |
Thromboembolic and major adverse cardiovascular events among
patients in the filgotinib clinical trial programme |
C Janneke van der Woude, Stefan Schreiber, Laurent Peyrin-Biroulet,
Zoltán Szekanecz, Ernest HS Choy, Pieter-Jan Stiers, Paul Van Hoek,
Katrien Van Beneden, Angela de Haas, Christine Rudolph and Hugo ten
Cate |
Poster presentationPresentation
number: P520Presentation date, time &
location: Friday 3 March 2023, 12:30-13:30, Poster
Exhibition, Hall B5&6 |
Investigating the symptom burden among European patients with
moderate-to-severe Crohn’s disease using a real-world survey |
Johan Burisch, Ailsa Hart, Andreas Sturm, Hannah Knight,
Christine Rudolph, Rachael Meadows, Alessandra Oortwijn, Sarah
Weatherby, Roger Rolph, Fatima Dawod and Alessandro Armuzzi |
Poster presentationPresentation
number: P624Presentation date, time &
location: Friday 3 March 2023, 12:30-13:30, Poster
Exhibition, Hall B5&6 |
About 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 people2 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
clinical program
The SELECTION program comprised of SELECTION and
the associated long-term extension study (SELECTIONLTE).
The SELECTION Phase 3 study was a multi-center,
randomized, double-blind, placebo-controlled study designed to
assess the safety and efficacy of the preferential JAK1 inhibitor
filgotinib in adult patients with moderate to severe active UC. The
SELECTION study (NCT02914522) comprised of two induction trials and
a maintenance trial. Induction Study A enrolled biologic-naïve
patients and Induction Study B enrolled biologic-experienced
patients. A majority of the patients included in the SELECTION
study (n=1348) had a pMCS of 9 or higher at baseline, and 43% of
biologic-experienced patients (n=297/689) had an insufficient
response to a TNF antagonist and vedolizumab as well.3
The primary objectives of the SELECTION clinical
program were to evaluate the efficacy of filgotinib compared with a
placebo in establishing clinical remission as determined by the
Mayo endoscopic sub-score, rectal bleeding sub-score, and decrease
in stool frequency from baseline. Patients who completed the
induction and maintenance studies, patients who were not responders
at Week 10, and patients with disease worsening during the
maintenance study were enrolled in the ongoing SELECTIONLTE study
(NCT02914535) to evaluate the long-term safety and efficacy of
filgotinib in patients suffering from UC. An interim report of
SELECTIONLTE assessed the safety and efficacy of open-label
filgotinib through to Week 144 in completers and through to Week
192 in non-responders, respectively.
About
filgotinibFilgotinib is marketed as Jyseleca® in
Europe and Japan for the treatment of adults with moderate to
severe active RA who have responded inadequately or are intolerant
to one or more disease modifying anti-rheumatic drugs. Filgotinib
is also marketed as Jyseleca® in Europe and Japan for the treatment
of adult patients with moderate to severe active UC who have had an
inadequate response with, lost response to, or were intolerant to
either conventional therapy or a biologic agent. Jyseleca® 100mg
and 200mg applications are registered in the above-mentioned
territories.
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, respectively. The
interview form from the Japanese Ministry of Health, Labour and
Welfare is available at www.info.pmda.go.jp.
Jyseleca® is a trademark of Galapagos NV and
Gilead Sciences, Inc. or its related companies. Except for
filgotinib’s approval as Jyseleca® for the treatment of moderate to
severe active RA and UC by the relevant regulatory authorities in
the European Union, Great Britain, and Japan, our drug candidates
are investigational; their efficacy and safety have not been fully
evaluated by any regulatory authority.
About GalapagosGalapagos is a
fully integrated biotechnology company focused on discovering,
developing, and commercializing innovative medicines. We are
committed to improving patients’ lives worldwide by targeting
diseases with high unmet needs. Our R&D capabilities cover
multiple drug modalities, including small molecules and cell
therapies Our portfolio comprises discovery through to
commercialized programs in immunology, oncology, and other
indications. Our first medicine for rheumatoid arthritis and
ulcerative colitis is available in Europe and Japan. For additional
information, please visit www.glpg.com or follow us
on LinkedIn or Twitter.
Contact
Media relations Marieke Vermeersch +32
479 490 603 Elisa Chenailler +41 79 853 33
54 Hélène de Kruijs +31 6
22463921 media@glpg.com |
Investor relations Sofie Van Gijsel +1
781 296 1143 Sandra Cauwenberghs +32 495 58 46
63 ir@glpg.com |
Forward Looking Statements
This press release includes forward-looking
statements, all of which involve certain risks and uncertainties.
These statements are often, but are not always, made through the
use of words or phrases such as “will,” “further,” “prolonged,”
“ongoing,” “estimated,” “over time,” “long-term,” and “consistent,”
as well as similar expressions. Forward-looking statements
contained in this press release include, but are not limited to,
statements related to our plans and strategy with respect to the
SELECTION and SELECTIONLTE study, statements related to the data
and the analysis of data from the SELECTION and SELECTIONLTE study,
and statements related to our plans and strategy with respect to
filgotinib. We caution the reader that forward-looking statements
are based on our management’s current expectations and beliefs and
are not guarantees of our future performance. Forward-looking
statements involve known and unknown risks, uncertainties and other
factors which might cause our actual results, performance or
achievements to be materially different from any historic or future
results, performance or achievements expressed or implied by such
statements. These risks, uncertainties and other factors include,
without limitation, the risk that ongoing and future clinical
studies with filgotinib may not be completed in the
currently envisaged timelines or at all, the inherent risks
and uncertainties associated with competitive developments,
clinical trials, recruitment of patients, product development
activities, and regulatory approval requirements (including,
without limitation, that data from the ongoing and planned clinical
research programs may not support registration or further
development of filgotinib due to safety, efficacy or
other reasons), including the filgotinib clinical program and the
SELECTION and SELECTIONLTE study, the risks related to continued
regulatory review of filgotinib following approval by relevant
regulatory authorities, including the European Medicines Agency’s
safety review of JAK inhibitors used to treat certain inflammatory
disorders, the risks that regulatory authorities may require
additional post-approval trials of filgotinib or any of our other
product candidates that may be approved in the future, our
reliance on collaborations with third parties (including Gilead),
the risk that our estimations regarding
our filgotinib development program and the commercial
potential of filgotinib may be incorrect, the risk that
we will not be able to continue to execute on our currently
contemplated business plan and/or will need to revise our business
plan, and risks related to the ongoing COVID-19 pandemic. A further
list and description of these risks, uncertainties, and other risks
can be found in our filings and reports with the U.S.
Securities and Exchange Commission (“SEC”), including in our most
recent annual report on Form 20-F filed with the SEC and our
subsequent filings and reports filed with the SEC. Given these
risks and uncertainties, the reader is advised not to place any
undue reliance on such forward-looking statements. In addition,
even if our results, performance or achievements are consistent
with such forward-looking statements, they may not be predictive of
results, performance or achievements in future periods. These
forward-looking statements speak only as of the date of publication
of this release. We expressly disclaim any obligation to update any
such forward-looking statements in this press release unless
required by law or regulation.
1 The Inflammatory Bowel Disease Questionnaire is a widely used
questionnaire for HRQoL assessment in patients with inflammatory
bowel diseases.
2 Burisch J. et al. Journal of Crohn’s and Colitis 2013;
7:322-337.
3 Feagan et al., Lancet 2021; 397: 2372–84.
- 230214_ECCO 2023 press release_final ENG
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