Mechelen, Belgium, 27
May 2021,
22:01 CET, – Galapagos NV
(Euronext & Nasdaq:
GLPG) today announced
that 15
abstracts, including scientific
updates, and data providing further understanding on the profile of
filgotinib as a treatment for people with Rheumatoid Arthritis
(RA), will be presented
at the European League Against Rheumatism (EULAR)
virtual congress 2021, 2-5 June.
New data analyses on the safety profile of
filgotinib, an oral, once-daily, JAK1 preferential inhibitor for
the treatment of moderately to severely active RA, are presented
from seven trials from the development program for filgotinib
(DARWIN 1 and 2 and FINCH 1, 2 and 3 and two long term extension
studies DARWIN 3 and FINCH 4). Data will be shared on the incidence
of infections and serious infections (OP0126) and herpes zoster
virus (POS0092), as well as the effects of concomitant use of
statins in filgotinib-treated patients with rheumatoid arthritis
(POS0660) and the effect of filgotinib on the pharmacokinetics of
rosuvastatin, atorvastatin, and pravastatin (AB0259).
Galapagos is also presenting scientific research
investigating the hypothesis that differences in the selectivity of
molecules in the JAK inhibitor class could result in a
differential functional modulation of natural killer (NK)
cells, which could be a component of the differences in clinical
safety profiles of JAK inhibitors (POS0224).
In addition to the clinical data, Galapagos will
present initial results from a European real-world survey
investigating patient and physician attitudes to setting treatment
target goals in RA, as a strategy for managing the disease
(POS0305).
“At Galapagos, we are working to understand the
different dimensions of treatment needs that people living with RA
say are important, reflecting a deeper understanding of their
complex lives and needs,” said Walid Abi-Saab, MD, Chief Medical
Officer at Galapagos. “In our drive to deliver innovation and make
a real difference where the patient need is greatest, we are
excited to be sharing a range of data and insights that represent
our ongoing work to understand what matters most to people living
with RA and to deliver on the health outcomes most important to
patients.”
The presentations at EULAR capture a broad range
of research and commitment to the RA community, demonstrating the
importance of patient and clinical insight and highlighting
Galapagos’ position as a science-driven company led by research
into patient unmet needs.
Galapagos Key Abstracts
Title |
Authors |
Oral | Poster Number |
Time and Date |
Herpes Zoster in the Filgotinib Rheumatoid Arthritis Program
|
Kevin Winthrop, et al |
POS0092 |
Poster tour: 03 June 2021, 11:50:00-13:30:00 CEST |
Infections and Serious Infections in the Filgotinib Rheumatoid
Arthritis Program |
James Galloway, et al |
OP0126 |
Session: 03 June 2021, 10:15:00-11:45:00 CEST |
Concomitant Use of Statins in Filgotinib-Treated Patients with
Rheumatoid Arthritis |
Peter C Taylor, et al |
POS0660 |
Display: Wednesday, 02 June 2021, 08:00 CEST – Saturday 05 June
2021, 23:59 CEST |
Evaluation of the effect of filgotinib on the pharmacokinetics of
rosuvastatin, atorvastatin, and pravastatin |
Kacey Anderson, et al |
AB0259 |
Publish: Abstract Book official supplement to the Annals of
Rheumatic Diseases ARD |
Selectivity of clinical JAK inhibitors and the impact on Natural
Killer (NK) cell functional responses |
Paqui G. Traves, et al |
POS0224 |
Poster tour: 04 June 2021, 11:50:00-13:30:00 CEST |
Physician and Patient Attitudes towards Treat-to-Target, its
Implementation and Stated Treatment Goals in Patients with
Rheumatoid Arthritis in a Real-World Setting across Europe |
Bruno Fautrel, et al |
POS0305 |
Poster tour: 05 June 2021, 10:30:00-12:00:00 CEST |
For further information on the EULAR congress
visit: www.congress.eular.org
For further details about the filgotinib
rheumatoid arthritis clinical trial program, visit
www.clinicatrials.gov: FINCH 1 NCT02889796; FINCH 2 NCT02873936;
FINCH 3 NCT02886728; FINCH 4 NCT03025308; DARWIN 1 NCT01888874;
DARWIN 2 NCT01894516; DARWIN 3 NCT02065700; FITZROY NCT02048618
About
rheumatoid
arthritisRA is a chronic
inflammatory disease. In RA a person's immune system attacks
healthy cells, causing painful swelling in affected parts of the
body, primarily in the joints.1 RA can cause tissue damage
resulting in chronic pain, unsteadiness and physical disability.1
More than 2.3 million individuals are living with RA in Europe2 and
women are 2 – 3 times more likely to develop RA.3 The onset of
disease is typically between 30 and 50 years of age.4
About
filgotinib Filgotinib 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 Great Britain Summary of Product
Characteristics is available at www.medicines.org.uk/emc.
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 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. Filgotinib is
not approved in any other countries.
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 Europe
and a global Phase 3 program is ongoing in Crohn’s Disease. More
information about clinical trials can be accessed at
www.clinicaltrials.gov.
About Galapagos Galapagos NV
discovers, develops, and commercializes small molecule medicines
with novel modes of action, several of which show promising patient
results and are currently in late-stage development in multiple
diseases. Our pipeline comprises discovery through Phase 3 programs
in inflammation, fibrosis and other indications. Our ambition is to
become a leading global biotech company focused on the discovery,
development and commercialization of innovative medicines. More
information at www.glpg.com.
- Centers for Disease Control and
Prevention. Rheumatoid Arthritis (RA). Available at:
https://www.cdc.gov/arthritis/basics/rheumatoid-arthritis.html.
Accessed September 2020.
- National Rheumatoid Arthritis
Society. The Burden of Rheumatoid Arthritis across Europe a
Socioeconomic Survey (BRASS). Summary Report. Available at:
https://www.nras.org.uk/data/files/Publications/Surveys%20Reports/UoC_HCD_BRASS%20Summary%20Report%20FINAL.pdf.
Accessed September 2020
- Arthritis Foundation. Arthritis by
the Numbers. Available at:
https://www.arthritis.org/getmedia/e1256607-fa87-4593-aa8a-8db4f291072a/2019-abtn-final-march-2019.pdf.
Accessed September 2020.
- Wasserman, A. Diagnosis and
Management of Rheumatoid Arthritis. American Family Physician.
Available at: https://www.aafp.org/afp/2011/1201/p1245.html.
Accessed September 2020
Contacts
Investors:Elizabeth GoodwinVP
Investor Relations +1 781 460 1784
Sofie Van GijselSenior Director Investor
Relations+32 485 19 14 15ir@glpg.com
Media:Carmen VroonenGlobal Head
of Communications & Public Affairs+32 473 824 874
Anna GibbinsSenior Director Therapeutic Areas
Communications+44 7717 801900communications@glpg.com
Forward
Looking StatementsThis 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, the risk
that the results of ongoing clinical studies with filgotinib will
not support continued approval of filgotinib 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) due to safety,
efficacy or other reasons or would not support approval of
filgotinib for any other indication, Galapagos’ reliance on
collaborations with third parties, including the collaboration with
Gilead for filgotinib, risks related to the implementation of
the transition of European commercialization responsibility for
filotinib from Gilead to us, 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.
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