Galapagos reports positive Phase 1 results for GLPG1690
February 16 2015 - 1:33AM
Galapagos NV (Euronext: GLPG) announced today that GLPG1690, a
first-in-class molecule for pulmonary disease, has demonstrated
target engagement, a good safety profile, and favorable drug
properties in a Phase 1 study. Galapagos is developing
GLPG1690 within its alliance with Janssen Pharmaceutica NV.
The aim of the Phase 1 study was to evaluate the safety,
tolerability, pharmacokinetics, and pharmacodynamics of oral single
and multiple ascending doses of GLPG1690. The randomized,
double-blind, placebo-controlled, single center study was conducted
in 40 healthy volunteers in Belgium. In the first part of the
study, single ascending doses were evaluated. In the second
part, the new compound was administered daily for 14
days.
GLPG1690 proved to be safe and well-tolerated over a wide dose
range in healthy volunteers. Engagement of the thus far
undisclosed novel target was confirmed using a relevant biomarker.
GLPG1690 displayed a favorable pharmacokinetic and pharmacodynamic
profile. The data shown in Phase 1 encourage Galapagos to
explore a Phase 2 study design in pulmonary disease.
"GLPG1690 is the first molecule against this target ever to be
evaluated clinically, and we are pleased with the outcome of the
Phase 1 study," said Dr Piet Wigerinck, CSO of Galapagos.
"Galapagos continues to deliver novel therapeutics from its unique
target and drug discovery engine."
In 2007, Galapagos announced an alliance agreement with Janssen
Pharmaceutica NV providing the option to worldwide, commercial
licenses to certain Galapagos internal inflammatory disease
programs. These programs are based on novel targets for
inflammatory disorders that were identified and validated by
Galapagos using its proprietary target discovery engine.
Subsequent Galapagos research led to the discovery of GLPG1690, a
first-in-class molecule that entered the clinic for inflammatory
disorders. Galapagos is responsible for execution of Phase 1
and Phase 2A studies with GLPG1690.
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 GLPG0634. GLPG0634 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 is a compound
that targets pulmonary diseases and is currently in a Phase 1
trial. 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
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activity timing, and other objectives and explanations, all of
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achievements of Galapagos, or industry results, to be materially
different from any historic or future results, financial
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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
reliance on such forward-looking statements. These
forward-looking statements speak only as of the date of publication
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HUG#1894402
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