Mechelen,
Belgium; 12 April 2018, 22.01 CET - Galapagos announces the design
of a worldwide Phase 3 program, based on feedback from the FDA and
EMA, to evaluate GLPG1690 in patients with idiopathic pulmonary
fibrosis. The planned ISABELA Phase 3 program with GLPG1690 is
intended to support both New Drug Application (NDA) and Market
Authorization Application (MAA) submissions in respectively the USA
and EU.
The global Phase 3 program is
expected to consist of two identically designed trials, ISABELA 1
and ISABELA 2. These will enroll patients diagnosed with IPF on top
of their local standard of care, whether or not they were
previously or currently are treated with Esbriet®[1]
(pirfenidone) and Ofev®[2]
(nintedanib). Recruitment will be worldwide, with a significant
proportion of patients in the USA and Europe. This Phase 3 program
is expected to start dosing in the second half of 2018.
ISABELA 1 and 2 are planned as
confirmatory trials and will enroll a total of 1,500 IPF patients
combined; patients will continue on their standard of care and will
be randomized to one of two doses of the oral investigational drug
GLPG1690 or placebo. The primary endpoint will be the rate of
decline of FVC[3] (in mL)
until week 52. Secondary assessments will include
respiratory-related hospitalizations, mortality, quality of life,
safety and tolerability.
All patients will continue on
their treatment until the last patient in their respective study
has completed 52 weeks of treatment. Therefore, some patients will
remain in the study for substantially longer than 52 weeks. This
approach will allow assessment of less frequent clinical events
that are otherwise difficult to assess in conventional clinical
studies of one-year duration.
"We are gratified to have feedback
on the registrational Phase 3 program from both the FDA and EMA in
a broad IPF population. ISABELA is aimed at providing information
to support application for a broad label in IPF patients,
potentially including monotherapy and add-on. We look forward to
starting ISABELA 1 and 2 trials to provide robust answers on
efficacy and safety of GLPG1690, an investigational IPF treatment
with an innovative mode of action," said Dr. Walid Abi-Saab, Chief
Medical Officer. "Today's announcement also marks another landmark
in our company's development; we will initiate our first
Galapagos-sponsored Phase 3 development program."
Galapagos will present three
abstracts on GLPG1690 at the American Thoracic Society Meeting in
San Diego in May 2018.
About
GLPG1690
GLPG1690 is a small molecule, selective autotaxin inhibitor which
is fully proprietary to Galapagos. Galapagos identified the
autotaxin target using its proprietary target discovery platform
and developed molecule GLPG1690 as an inhibitor of this target.
Oral investigational drug GLPG1690 showed promising results in
relevant pre-clinical models for IPF, and there is growing evidence
in scientific literature that autotaxin plays a role in this
disease. GLPG1690 appeared to halt disease progression as measured
by FVC at 12 weeks and was well-tolerated by IPF patients in the
FLORA Phase 2a trial reported in August 2017. Galapagos received
orphan drug designation for GLPG1690 in IPF from the U.S. Food
& Drug Administration (FDA) and European Commission (EC).
GLPG1690 is an investigational drug and its efficacy and safety
have not been established.
Preliminary information for
patients and healthcare professionals to be found at
www.isabelastudies.com. For more information about GLPG1690:
www.glpg.com/glpg-1690.
About IPF
IPF is a chronic, relentlessly progressive fibrotic disorder of the
lungs that typically affects adults over the age of 40. IPF affects
approximately 200,000 patients in the United States and Europe and,
as such, we have received orphan designation for our product
candidate GLPG1690 in IPF from the European Commission and from the
FDA. The clinical prognosis of patients with IPF is poor, as
survival at diagnosis is two to four years. Currently, no medical
therapies have been found to cure IPF. The medical treatment
strategy aims to slow disease progression and improve quality of
life. Lung transplantation may be an option for appropriate
patients with progressive disease and minimal comorbidities.
Regulatory agencies have approved
Esbriet® (pirfenidone)
and Ofev® (nintedanib)
for the treatment of mild to moderate IPF. Both Esbriet and Ofev
have been shown to slow the rate of functional decline in IPF and
are gaining ground as the standard of care worldwide. Combined
sales of both drugs reached $1.1 billion in 2016, with 74% of
global revenues being in the United States. These regulatory
approvals represent a major breakthrough for IPF patients; yet
neither drug improves lung function, and the disease in most
patients on these therapies continues to progress. Moreover, the
adverse effects associated with these therapies are considerable
(e.g., diarrhea, liver function test abnormalities with Ofev,
nausea and rash with Esbriet). Therefore, there is still a large
unmet medical need as IPF remains a major cause of morbidity and
mortality. We estimate global sales of approved IPF drugs will grow
to nearly $5 billion in 2025.
About Galapagos
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage
biotechnology company specialized in the discovery and development
of small molecule medicines with novel modes of action. Galapagos'
pipeline comprises Phase 3 through to discovery programs in cystic
fibrosis, inflammation, fibrosis, osteoarthritis and other
indications. Our target discovery platform has delivered three
novel mechanisms showing promising patient results in,
respectively, inflammatory diseases, idiopathic pulmonary fibrosis
and atopic dermatitis. Galapagos is focused on the development and
commercialization of novel medicines that will improve people's
lives. The Galapagos group, including fee-for-service subsidiary
Fidelta, has approximately 600 employees, operating from its
Mechelen, Belgium headquarters and facilities in the Netherlands,
France, Switzerland, the United States and Croatia. More
information at www.glpg.com.
Investors:
Elizabeth Goodwin
VP IR & Corporate Communications
+1 781 460 1784
Paul van der Horst
Director IR & Business Development
+31 71 750 6707
ir@glpg.com
Media:
Evelyn Fox
Director Communications
+31 6 53 591 999
communications@glpg.com
Forward-looking
statements
This release may contain forward-looking
statements, including, among other things, statements regarding
Galapagos' strategic ambitions, the mechanism of action and
potential activity of GLPG1690, the anticipated timing of future
clinical trials with GLPG1690, the progression and results of such
trials, and Galapagos' interactions with regulatory authorities.
Galapagos cautions the reader that forward-looking statements are
not guarantees of future performance. Forward-looking statements
involve known and unknown risks, uncertainties and other factors
which might cause the actual results, financial condition and
liquidity, performance or achievements of Galapagos, or industry
results, to be materially different from any historic or future
results, financial conditions and liquidity, performance or
achievements expressed or implied by such forward-looking
statements. In addition, even if Galapagos' results, performance,
financial condition and liquidity, and the development of the
industry in which it operates are consistent with such
forward-looking statements, they may not be predictive of results
or developments in future periods. Among the factors that may
result in differences are that Galapagos'
expectations regarding its GLPG1690 development program may be
incorrect, the inherent uncertainties associated with competitive
developments, clinical trial and product development activities and
regulatory approval requirements (including that data from
Galapagos' ongoing clinical research programs may not support
registration or further development of GLPG1690 due to safety,
efficacy or other reasons), Galapagos' reliance on collaborations
with third parties, and estimating the commercial potential of
GLPG1690. A further list and description of these risks,
uncertainties and other risks can be found in Galapagos' Securities
and Exchange Commission (SEC) filings and reports, including in
Galapagos' most recent annual report on Form 20-F filed with the
SEC and other filings and reports filed by Galapagos with the SEC.
Given these uncertainties, the reader is advised not to place any
undue reliance on such forward-looking statements. These
forward-looking statements speak only as of the date of publication
of this document. Galapagos expressly disclaims any obligation to
update any such forward-looking statements in this document to
reflect any change in its expectations with regard thereto or any
change in events, conditions or circumstances on which any such
statement is based or that may affect the likelihood that actual
results will differ from those set forth in the forward-looking
statements, unless specifically required by law or
regulation.
[1]
Esbriet® (pirfenidone)
is indicated for the treatment of IPF by Roche/Genentech.
[2]
Ofev® (nintedanib)
is indicated for the treatment of IPF by Boehringer Ingelheim.
[3] FVC=forced
vital capacity
ISABELA
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Galapagos NV via Globenewswire
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