Study uses mobile device technology to support capture of
patient-reported outcomes during early and ongoing use of study
treatment amongst patients with rheumatoid arthritis
Mechelen,
Belgium; 18
May 2021;
22.01
CET; –
Galapagos NV (Euronext & Nasdaq: GLPG) today
announced that the first patient has been
enrolled in the
FILOSOPHY Phase 4 European
real-world outcomes study. The goal
of the FILOSOPHY study is
to advance understanding of the effectiveness and safety of
filgotinib as it is used with patients
with rheumatoid
arthritis (RA) in
clinical practice.
The study, with target enrollment of 1500
patients across Europe, will evaluate the effectiveness, safety,
and patient-reported outcomes (PROs) in patients with moderate to
severe active RA while receiving filgotinib in a real-world setting
for up to two years. Mobile device technology will play a central
role in collection of PROs, allowing data collection to begin
within the first weeks of treatment. This may also prove to be an
effective tool during the pandemic, while in-person clinic visits
are harder to achieve.
FILOSOPHY will enable the gathering of
comprehensive real-world data in a population that may not be fully
represented in clinical trials, as randomized, placebo-controlled
trials require strict patient inclusion criteria. These data will
expand the evidence base to support the appropriate use of
filgotinib in clinical practice.
Dr. Walid Abi-Saab, Chief Medical Officer of
Galapagos said, “This study can enhance our understanding about the
effectiveness and safety of filgotinib from the experiences of RA
patients who are prescribed the treatment in a real-world
healthcare setting. We aim to improve disease management and
outcomes for people living with this debilitating condition.”
Professor Gerd Burmester, Director Department of
Rheumatology and Clinical Immunology, Charité, Universitätsmedizin,
Berlin and FILOSOPHY Steering Committee Member, added, “We expect
that use of remote devices to collect treatment outcomes data will
give us more comprehensive insights into early treatment effects in
relation to patient reported outcomes, including pain and fatigue.
In addition, we are interested to understand how long patients stay
on treatment and how this could be affected by patient
characteristics or treatment effects.”
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 RA3. The onset of
disease is typically between 30 and 50 years of age4.
About the FILOSOPHY
Phase 4 studyFILOSOPHY
(FILgotinib Observational Study Of Patient Health related outcomes
over 2 Years), is a prospective, non-interventional cohort study
enrolling approximately 1500 patients across Europe. Data will be
collected by the clinical sites and patients using an electronic
case report form (eCRF) and mobile devices. Each enrolled patient
will be followed for 24 months or until discontinuation of study,
whichever occurs first. Baseline assessments may be collected
within 30 days prior to the first dose of filgotinib.
The primary objective of the study is to
evaluate the treatment persistence rate at 24 months, defined as
the rate of patients continuing to receive filgotinib 24 months
from treatment initiation. Secondary and exploratory objectives
include effectiveness, evaluation of the effect of filgotinib on
patient reported outcomes (PROs) including on pain, fatigue and
work productivity, rate of adverse events (AEs) and serious adverse
events (SAEs) as well as adverse events of interest, including
serious and opportunistic infections (including herpes zoster),
major adverse cardiovascular events (MACE), venous thromboembolism
(VTE), hyperlipidemia, malignancies, non-melanoma skin cancer
(NMSC), and gastrointestinal (GI) perforation.
For more information go to ClinicalTrials.gov
Identifier: NCT04871919
About filgotinib Filgotinib is
approved and marketed as Jyseleca (200mg and 100mg tablets) in the
Europe 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 (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.
Filgotinib is not approved in any other jurisdictions.
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 Japan 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. 2011;84(11):1245-1252.
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 FILOSOPHY study, competitive
developments, and regulatory approval requirements, the risk that
the results of the FILOSOPHY study will not support continued
approval of Jyseleca 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, 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 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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