Galapagos initiates Phase 1 study with GLPG1690, triggering EU6.6 M milestone in the alliance with Janssen Pharmaceutica NV
01 Julho 2014 - 2:37AM
Mechelen, Belgium; 1 July 2014 - Galapagos NV (Euronext: GLPG)
announced today that GLPG1690, a first-in-class molecule aimed at
treating pulmonary diseases, has been dosed in a Phase 1
First-in-Human study. Galapagos will receive a €6.6 million
milestone payment from Janssen Pharmaceutica NV for this
achievement.
The aim of the Phase 1 study is 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
is being conducted in at least 40 healthy volunteers in Belgium.
In the first part of the study, single ascending doses will
be evaluated. In the second part, the new compound will be
administered daily for 14 days.
GLPG1690 has a novel mode of action discovered
by Galapagos, with potential application in pulmonary diseases. The
mode of action of GLPG1690 is different from that of another novel
mode of action clinical compound in the alliance with Janssen,
GLPG1205, currently being prepared for a Phase 2A program in
inflammatory bowel disease (IBD).
"The alliance with Janssen has produced a third
first-in-class compound to reach clinical development," said 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 include 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
pulmonary disorders. Galapagos is responsible for execution
of Phase 1 and Phase 2A studies with GLPG1690.
About Galapagos Galapagos
(Euronext: GLPG; OTC: GLPYY) is specialized in novel
modes-of-action, with a large pipeline comprising five Phase 2
studies (two led by GSK), two Phase 1 studies, four pre-clinical,
and 20 discovery small-molecule and antibody programs in cystic
fibrosis, inflammation, antibiotics, metabolic disease, and other
indications. In the field of inflammation, AbbVie and
Galapagos signed a worldwide license agreement whereby AbbVie will
be responsible for further development and commercialization of
GLPG0634 after Phase 2B. 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.
Galapagos has another selective JAK1 inhibitor in Phase 2 in
ulcerative colitis and psoriasis, GSK2586184 (formerly GLPG0778,
in-licensed by GlaxoSmithKline in 2012). GLPG0974 is the
first inhibitor of FFA2 to be evaluated clinically for the
treatment of IBD; this program has completed a Proof-of-Concept
Phase 2 study. GLPG1205 is a first-in-class molecule that
targets inflammatory disorders and has completed Phase 1.
GLPG1690 is a first-in-class compound that targets pulmonary
diseases and is currently in a Phase 1 study. AbbVie and
Galapagos signed an agreement in CF whereby they work
collaboratively to develop and commercialize oral drugs that
address two mutations in the CFTR gene, the G551D and F508del
mutation. Potentiator GLPG1837 is at the pre-clinical
candidate stage. The Galapagos Group, including
fee-for-service subsidiary Fidelta, has around 400 employees,
operating from its Mechelen, Belgium headquarters and facilities in
The Netherlands, France, and Croatia. Further information at:
www.glpg.com
CONTACT
For media and investor inquiries:Elizabeth
Goodwin, Head of Corporate Communications & Investor
RelationsTel: +31 6 2291 6240ir@glpg.com
This release may contain forward-looking
statements, including, without limitation, statements containing
the words "believes," "anticipates," "expects," "intends," "plans,"
"seeks," "estimates," "may," "will," "could," "stands to," and
"continues," 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
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expressed or implied by such forward-looking statements. Given
these uncertainties, the reader is advised not to place any undue
reliance on such forward-looking statements. These forward-looking
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change in its expectations with regard thereto or any change in
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based, unless required by law or regulation.
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