Galapagos initiates a Phase 2a study with GLPG1690 in idiopathic pulmonary fibrosis patients
April 06 2016 - 4:09PM
Galapagos NV (Euronext & NASDAQ: GLPG) announced the start
of its exploratory Phase 2a study with GLPG1690 in idiopathic
pulmonary fibrosis (IPF) patients, named
FLORA.
FLORA is a randomized, double-blind,
placebo-controlled study investigating a once daily oral dose of
GLPG1690 administered for 12 weeks in 24 IPF patients. Primary
objectives of the study are to assess safety, tolerability,
pharmacokinetics and pharmacodynamics of GLPG1690 in an IPF patient
population. Target engagement will be measured by LPA in
plasma and bronchoalveolar lavage fluid, both at baseline and
through twelve weeks of treatment. Secondary objectives
include the evaluation of lung function, changes in disease
biomarkers and quality of life. Galapagos expects to complete
patient recruitment before end 2016, and to report topline results
in Q2 2017.
GLPG1690 is a small molecule inhibitor of
autotaxin and fully proprietary to Galapagos.
"We identified the autotaxin target using our
proprietary target discovery platform and developed molecule
GLPG1690 as an inhibitor of this target. GLPG1690 shows
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. We are pleased to be able to
investigate the effect of GLPG1690 in IPF patients and look forward
to seeing the results in the first half of next year," said Dr Piet
Wigerinck, Chief Scientific Officer of Galapagos.
About IPF IPF is a chronic, relentlessly progressive
fibrotic disorder of the lungs that typically affects adults over
the age of 40. According to an April 2013 GlobalData EpiCast
report, the prevalence of IPF is <30 per 100,000 persons in both
Europe and the United States, and as such, IPF is considered a rare
disease. The clinical prognosis of patients with IPF is poor
as the median survival at diagnosis is 2-5 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 maturing pipeline comprises Phase 2, Phase 1,
pre-clinical candidates and discovery studies 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 440 employees, operating from its Mechelen, Belgium
headquarters and facilities in The Netherlands, France, and
Croatia. More information at www.glpg.com.
CONTACT
Investors: Media:
Elizabeth
Goodwin Evelyn
Fox VP IR & Corporate
Communications Director
Communications +1 781 460
1784 +31
6 53 591 999
ir@glpg.com communications@glpg.com
Forward-Looking Statements
This release may contain forward-looking statements, including
statements regarding the anticipated timing of clinical studies
with GLPG1690 and the progression and results of such
studies. 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 GLPG1690, the inherent
uncertainties associated with competitive developments, clinical
trial and product development activities and regulatory approval
requirements, 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' 20-F filing for 2015 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
idiopathic pulmonary fibrosis (IPF) by Roche/Genentech.
[2] Ofev® (nintedanib) is indicated for the treatment of
idiopathic pulmonary fibrosis (IPF) by Boehringer Ingelheim.
GLPG starts Phase 2a study in IPF
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