Galapagos reports positive Phase 1 results for GLPG1690
(Thomson Reuters ONE) -
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(at)glpg.com
Galapagos forward-looking statements
This release may contain forward-looking statements, including, without
limitation, statements concerning anticipated progress, objectives and
expectations regarding the commercial potential of our product candidates,
intended product development, clinical activity timing, and other objectives and
explanations, all of which involve certain risks and uncertainties. These
statements are often, but are not always, made through the use of words or
phrases such as "believes," "anticipates," "expects," "intends," "plans,"
"seeks," "estimates," "may," "will," "could," "stands to," "continues," "we
believe," "we intend," as well as similar expressions. Such forward-looking
statements may involve known and unknown risks, uncertainties and other factors
which might cause the actual results, financial condition, performance or
achievements of Galapagos, or industry results, to be materially different from
any historic or future results, financial conditions, performance or
achievements expressed or implied by such forward-looking 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 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, unless 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
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