Galapagos presents promising pre-clinical and Phase 1 results with autotaxin inhibitor GLPG1690 at ERS
(Thomson Reuters ONE) -
Mechelen, Belgium; 22 September 2015: Galapagos NV (Euronext & NASDAQ: GLPG)
presents pre-clinical and Phase 1 results for autotaxin inhibitor GLPG1690 at
the European Respiratory Society Annual Meeting in Amsterdam, Netherlands.
Galapagos expects to file an exploratory Phase 2 study in idiopathic pulmonary
fibrosis before year end. GLPG1690 has potential application in other pulmonary
diseases such as chronic obstructive pulmonary disease (COPD), as supported by
the presentation on pre-clinical findings at ERS this year:
"Pharmacological profile and efficacy of GLPG1690, a novel ATX inhibitor for
COPD treatment," poster PA2129 in Poster Discussion Session: "New targets and
modalities for the treatment of asthma and COPD" (September 28, 2015; Room D201-
202, 10:45 AM - 12:45 PM)
Galapagos is the first to show efficacy of an autotaxin inhibitor in pre-
clinical models for COPD and IPF, pointing to novel therapeutic areas for
autotaxin inhibition. The poster shows how GLPG1690 acts as a potent inhibitor
of mouse and human autotaxin (IC(50): 100 -500 nM range). Furthermore, GLPG1690
reduces inflammation in a mouse steroid-resistant tobacco smoke model to a
similar extent as a standard therapy for COPD.
Galapagos also presents the topline results with GLPG1690 in Phase 1 in healthy
human volunteers: "Favorable human safety, pharmacokinetics and
pharmacodynamics of the autotaxin inhibitor GLPG1690, a potential new treatment
in COPD," oral presentation OA484 in session "Advances in the future treatment
of COPD" (September 27, 2015; Room 2.1, 10:45 AM - 12:45 PM)
GLPG1690 was safe and well tolerated up to a single oral dose of 1500 mg and up
to 1000 mg twice daily for 14 days, with no significant adverse effects on ECGs,
vital signs or laboratory parameters. The compound also showed good oral
bioavailability with a half-life of 5 hours and a dose-proportional increase in
exposure. GLPG1690 showed concentration-dependent reduction of a relevant
biomarker (plasma LPA18:2 levels) with a maximum of approximately 90%. At
steady state, continuous reduction of this biomarker levels of >60% was observed
from 0 to 24 hours. The presentation will also include relevant pre-clinical
model data for COPD and IPF with GLPG1690.
Both the presentation and the posters will be made available on the Galapagos
website after the conference.
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, with a pipeline comprising three Phase 2 programs, two
Phase 1 trials, five pre-clinical studies, and 20 discovery small-molecule and
antibody programs in cystic fibrosis, inflammation, and other indications. In
the field of inflammation, AbbVie and Galapagos signed a collaboration agreement
for the development and commercialization of filgotinib. Filgotinib is an
orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid
arthritis and potentially other inflammatory diseases, currently in Phase 2B
studies in RA and in Phase 2 in Crohn's disease. Galapagos reported good
activity and a favorable safety profile in both the DARWIN 1 and 2 trials in
RA. AbbVie and Galapagos also signed a collaboration agreement in cystic
fibrosis to develop and commercialize molecules that address mutations in the
CFTR gene. Potentiator GLPG1837 is currently in a Phase 1 trial, and corrector
GLPG2222 is at the pre-clinical candidate stage. GLPG1205, a first-in-class
inhibitor of GPR84 and fully-owned by Galapagos, is currently being tested in a
Phase 2 proof-of-concept trial in ulcerative colitis patients. GLPG1690, a
fully proprietary, first-in-class inhibitor of autotaxin, has shown favorable
safety in a Phase 1 trial and is expected to enter Phase 2 in idiopathic
pulmonary fibrosis. The Galapagos Group, including fee-for-service subsidiary
Fidelta, has approximately 400 employees, operating from its Mechelen, Belgium
headquarters and facilities in The Netherlands, France, and Croatia. More info
at www.glpg.com
CONTACT
Galapagos NV
Elizabeth Goodwin, Head of Corporate Communications & IR
Tel: +31 6 2291 6240
ir(at)glpg.com
Galapagos forward-looking statements
This release may contain forward-looking statements, including without
limitation statements regarding the possibility and timing of the initiation of
Phase 2 activities in idiopathic pulmonary fibrosis, GLPG1690's potential
application in other pulmonary diseases and GLPG1690's safety and/or efficacy
profile. 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 Galapagos' ongoing DARWIN and
FITZROY programs with filgotinib may not support registration or further
development of filgotinib due to safety, efficacy or other reasons), Galapagos'
reliance on collaborations with third parties (including its collaboration
partner for filgotinib, AbbVie, who may not in-license filgotinib or, if it
does, may not devote sufficient resources to the development and
commercialization of filgotinib), 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 filing and reports, including in Galapagos' prospectus filed with the
SEC on May 14, 2015 and future filings and reports by Galapagos. 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.
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Galapagos NV via GlobeNewswire
[HUG#1953595]
Unternehmensinformation / Kurzprofil:
Datum: 22.09.2015 - 07:31 Uhr
Sprache: Deutsch
News-ID 421615
Anzahl Zeichen: 8418
contact information:
Town:
Mechelen
Kategorie:
Business News
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