Galapagos regains rights to GLPG1690, announces end of alliance with Janssen
March 17 2015 - 2:37AM
- Fully owned and proprietary clinical asset for pulmonary
fibrosis
- GLPG1690 acts on autotaxin target
- Novel mode of action, originating from Galapagos target
discovery engine
- Filing for Phase 2 clinical trial in 2015
MECHELEN, Belgium, March 16, 2015 (GLOBE
NEWSWIRE) -- Galapagos NV (Euronext: GLPG) announced
that Janssen Pharmaceutica NV and Galapagos have mutually agreed to
terminate the inflammation alliance and option agreements between
the companies. Galapagos views the molecules emerging from
the alliance as strong additions to its growing proprietary
pipeline. Among others, all rights to candidate drug
GLPG1690, a selective autotaxin inhibitor, return to
Galapagos. Galapagos has successfully completed a
First-in-Human Phase 1 trial for GLPG1690 and is preparing a Phase
2 clinical trial in idiopathic pulmonary fibrosis
(IPF).
"We are pleased to regain the rights to GLPG1690
to pursue the most suitable clinical application of autotaxin
inhibition. There is a large unmet medical need in IPF, and
our pre-clinical data with GLPG1690 supports its potential as a
competitive and novel approach in this disease area," said Dr Piet
Wigerinck, Chief Scientific Officer of Galapagos. "The
alliance with Janssen has been underway since October 2007 and has
generated three clinical molecules, two of which are now
proprietary Phase 2 assets of Galapagos: GLPG1205 and
GLPG1690. This program is a valuable component of our
development portfolio, and regaining the rights is a next step in
our transformation into a mature biotech company with a proprietary
product pipeline."
Galapagos identified autotaxin as playing a key
role in inflammation, using an inflammation assay in its unique
target discovery platform. Pharmacology and translational
studies published by other parties in the literature since then
suggest autotaxin may play a key role in metabolic disease,
arthritic pain, oncology, and lung disease.
GLPG1690 is a potent and selective inhibitor of
autotaxin. In a Phase 1 study in healthy human volunteers,
GLPG1690 demonstrated favorable safety and tolerability, as well as
a strong pharmacodynamic signal implying target engagement.
Galapagos is currently preparing a Phase 2 study in IPF, to be
filed for approval before the end of 2015.
About IPF Idiopathic pulmonary fibrosis
(IPF) is a chronic and ultimately fatal disease characterized by a
progressive decline in lung function. Pulmonary fibrosis
involves scarring of lung tissue and is the cause of shortness of
breath. Fibrosis is usually associated with a poor prognosis.
The term "idiopathic" is used because the cause of pulmonary
fibrosis is still unknown. Estimated incidence of IPF is up
to 16.3 per 100,000 persons in the US and 7.4 per 100,000 persons
in Europe, with approximately 30,000-35,000 new patients diagnosed
with IPF worldwide each year. The goals of treatment in IPF
are essentially to reduce the symptoms, slow down disease
progression, reduce acute exacerbations, and prolong survival.
Approved treatments thus far have improved the overall
survival of IPF patients, but unwanted side effects with these
treatments are common, presenting an unmet need for effective
treatments with safer side effect profiles.
About Galapagos Galapagos (Euronext:
GLPG; OTC: GLPYY) 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 25 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. GLPG1205, a
first-in-class inhibitor of GPR84, is currently being tested in a
Phase 2 proof-of-concept trial in ulcerative colitis
patients. GLPG1690, a 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. 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. 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. Further information 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,
expectations regarding the commercial potential of our product
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statements. Among the factors that may result in differences
are the inherent uncertainties associated with competitive
developments, clinical trial and product development activities,
regulatory approval requirements and estimating the commercial
potential of our product candidates. Given these
uncertainties, the reader is advised not to place any undue
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forward-looking statements speak only as of the date of publication
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