Galapagos presents promising pre-clinical and Phase 1 results with autotaxin inhibitor GLPG1690 at ERS
September 22 2015 - 1:37AM
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 (IC50: 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@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.
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