Galapagos reports positive Phase 1 results for GLPG1690
16 Febbraio 2015 - 7:30AM
Mechelen,
Belgium; 16 February 2015 - 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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Source: Galapagos NV via Globenewswire
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