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 GLPG1690GLPG1690 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 IPFIPF 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 GalapagosGalapagos (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 GoodwinVP IR &
Corporate Communications +1 781 460 1784
Paul van der HorstDirector IR & Business
Development +31 71 750 6707ir@glpg.com
Media:Evelyn FoxDirector Communications
+31 6 53 591 999 communications@glpg.com
Forward-looking statementsThis 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
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