-
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.
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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