Galapagos initiates a Phase 2a study with GLPG1690 in idiopathic pulmonary fibrosis patients
(Thomson Reuters ONE) -
Mechelen, Belgium; 6 April 2016 - 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(at)glpg.com communications(at)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:
http://hugin.info/133350/R/2001303/738369.pdf
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Source: Galapagos NV via GlobeNewswire
[HUG#2001303]
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Datum: 06.04.2016 - 22:00 Uhr
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