- Forced vital capacity (FVC) in lungs stabilized over the
12-week treatment period, placebo arm showed expected
decline
- Functional respiratory imaging (FRI) confirms FVC data with
statistical significance
- GLPG1690 was generally well tolerated
- First autotaxin inhibitor to show effect in IPF patient
trial
- GLPG1690 expected to progress to late stage trial
Webcast presentation of the results to
be held tomorrow 10 August, 14.00 CET/8 AM EDT, +32 2 404
0659, access code 2084135; more call number info further down
Mechelen, Belgium; 9 August 2017; 22.01 CET;
regulated information - Galapagos NV (Euronext & NASDAQ: GLPG)
announces positive topline results with its autotaxin inhibitor
GLPG1690 in patients with idiopathic pulmonary fibrosis (IPF) in
the FLORA Phase 2a trial.
FLORA was an exploratory, randomized,
double-blind, placebo-controlled trial investigating a once-daily
oral dose of GLPG1690. The drug candidate was administered for 12
weeks in 23 IPF patients, 17 of whom received GLPG1690 and 6
placebo. Primary objectives of the trial were to assess safety,
tolerability, pharmacokinetics and pharmacodynamics of GLPG1690 in
an IPF patient population. Secondary objectives included the
evaluation of lung function, changes in disease biomarkers, FRI,
and quality of life. The IPF diagnosis was confirmed by central
reading. The baseline characteristics of the recruited population
were in line with published data in similarly conducted studies and
were balanced between active and placebo. Patients with previous
experience on nintedanib or pirfenidone were required to have
discontinued treatment with either agent for at least 4 weeks prior
to initiating treatment with GLPG1690.
Over the 12-week period, patients receiving
GLPG1690 showed an FVC increase of 8 mL, while patients on placebo
showed an FVC reduction of 87 mL (mean from baseline). Such
reductions in FVC in the placebo arm were in line with expectations
based on similarly conducted third-party studies in IPF patients.
In addition to the demonstrated absence of lung function decline
over the 12 week period, more sensitive functional respiratory
imaging (FRI) confirmed disease stabilization in the GLPG1690 arm,
versus disease progression in the placebo arm, reaching statistical
significance on two specific parameters.
Patients on GLPG1690 treatment showed a clear
reduction of serum LPA18:2, a biomarker for autotaxin inhibition,
as expected based on the mechanism of action of GLPG1690. Thus, the
level of target engagement observed in Phase 1 with healthy
volunteers was confirmed in IPF patients in FLORA.
GLPG1690 was found to be generally well
tolerated in this Phase 2 trial. Rates of discontinuation due to
adverse events, as well as serious adverse event rates, were
similar between patients on GLPG1690 and placebo.
Galapagos plans to rapidly progress GLPG1690 in
a late stage trial and had already discussions with regulators
regarding trial design.
"Galapagos' results with GLPG1690 are extremely
exciting and exceed those of previous studies. This brings hope to
patients with idiopathic pulmonary fibrosis that new effective
treatment may be on the horizon. Importantly, some patients even
showed an increase of lung function within only 12 weeks of
treatment, and the drug was well tolerated. The results from FLORA
beg the question how patients will fare with longer treatment. I
urge Galapagos and the IPF community to progress to the next phase
of clinical trials as rapidly as possible," said Dr. Toby Maher,
Professor of Interstitial Lung Disease at Imperial College, London
and Consultant Physician at Royal Brompton Hospital, London.
"Not only does GLPG1690 show early promise as a
potential therapy for IPF, but it also marks an important milestone
for Galapagos as a company: proof of concept in patients of a
second mechanism of action coming from our target discovery
platform. Galapagos has shown that this platform continues to
deliver novel mechanisms of action beyond JAK1 in inflammation. The
stabilization of FVC over 12 weeks upon GLPG1690 treatment is a
major milestone in IPF, where, by way of reference, the currently
approved treatments show a decrease of approximately 30 mL over the
same treatment period," added Dr. Piet Wigerinck, Chief Scientific
Officer of Galapagos.
Galapagos plans to report the FLORA study
results at a future medical conference.
Conference call and webcast
presentation
Galapagos will conduct a conference call open to
the public tomorrow, 10 August 2017, at
14:00 CET / 8 AM EDT, which will also be
webcasted. To participate in the conference call, please call one
of the following numbers ten minutes prior to commencement:
Confirmation
Code: 2084135
Belgium:
+32 2 404 0659
France:
+33 1 7677 2274
Netherlands:
+31 20 721 9251
United
Kingdom:
+44 330 336 9411
United
States:
+1 719 325 2226
A question and answer session will follow the
presentation of the results. Go to www.glpg.com to access the live
audio webcast. The archived webcast, PDF of the slides, and a
transcript will also be available on the Galapagos website later in
the day.
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. 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 successfully completed a Phase 1 trial in 2015,
showing favorable findings relating to safety and tolerability, and
high target engagement in healthy volunteers. 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.
For information about the studies with GLPG1690:
www.clinicaltrials.gov
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. There are approximately 200,000 patients with IPF in
the U.S. and Europe, with 75,000 newly diagnosed patients per year.
As such, IPF is considered a rare disease. The clinical prognosis
of patients with IPF is poor as the median survival at diagnosis is
2 to 5 years. Currently, no medical therapies have been found to
cure IPF. The medical treatment strategy aims to slow the disease
progression and improve the quality of life. Lung transplantation
may be an option for appropriate patients with progressive disease
and minimal comorbidities.
Regulatory agencies have approved Esbriet®[1]
(pirfenidone) and Ofev®[2] (nintedanib) for the treatment of IPF.
Both pirfenidone and nintedanib have been shown to slow the rate of
lung function decline in IPF and are likely to become the standard
of care worldwide. These regulatory approvals represent a major
breakthrough for IPF patients; yet neither drug improves lung
function, and the disease continues to progress in the majority of
patients despite treatment. Moreover, the adverse effects
associated with these therapies include diarrhea, liver function
test abnormalities with nintedanib, nausea and rash with
pirfenidone. Therefore, there is still a large unmet medical need
as IPF remains a major cause of morbidity and mortality.
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. Our pipeline comprises Phase 3, Phase 2, Phase 1,
pre-clinical, and discovery programs in cystic fibrosis,
inflammation, fibrosis, osteoarthritis and other indications. We
have discovered and developed filgotinib: in collaboration with
Gilead we aim to bring this JAK1-selective inhibitor for
inflammatory indications to patients all over the world. 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 550
employees, operating from its Mechelen, Belgium headquarters and
facilities in The Netherlands, France, and Croatia. More
information at www.glpg.com.
Contact
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
This press release contains inside information
within the meaning of Regulation (EU) No 596/2014 of the European
Parliament and of the Council of 16 April 2014 on market abuse
(market abuse regulation).
Forward-looking statements
This release may contain forward-looking
statements, including statements regarding Galapagos' strategic
ambitions, the potential activity of GLPG1690, the anticipated
timing of future clinical studies with GLPG1690, the progression
and results of such studies, 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 the inherent uncertainties associated
with competitive developments, clinical trial and product
development activities and regulatory approval requirements
(including that data from the ongoing and planned 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 Galapagos' product candidates. 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 subsequent 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.
Galapagos NV (NASDAQ:GLPG)
Historical Stock Chart
From Aug 2024 to Sep 2024
Galapagos NV (NASDAQ:GLPG)
Historical Stock Chart
From Sep 2023 to Sep 2024