MECHELEN, BELGIUM--(Marketwire - May 11, 2011) -
·Following successful outcome of first-in-human trial for GLPG0778
·Phase I study measures effect on biomarker in healthy volunteers
Mechelen, Belgium; 11 May 2011 - Galapagos NV (Euronext: GLPG) announced
today
that it has initiated a second Phase I Proof of Mechanism study in its
immuno-inflammation alliance with GlaxoSmithKline. This new study follows
the positive
outcome of the first-in-human trial conducted for GLPG0778, which showed an
acceptable safety and pharmacokinetics profile in healthy volunteers for
one-
week dosing and an initial biomarker response. The Proof of Mechanism study
is
aimed at assessing GLPG0778's effect on a specific target in healthy
volunteers.
Galapagos plans to conduct the multiple ascending dose study in 45 healthy
volunteers using five two-week dosing regimens. In this Proof of Mechanism
study, GPLG0778's ability to suppress an induced inflammatory response in
healthy volunteers will be evaluated. In addition to measuring the
biomarker
response, the safety, tolerability and pharmacokinetics of candidate drug
GLPG0778 will be assessed further. Galapagos aims to report the study
results
in the fourth quarter of 2011. GSK has an exclusive option to in-license
this
compound.
"With the initiation of this study, we could demonstrate clinical proof of
mechanism for GLPG0778 this year," said Onno van de Stolpe, CEO of
Galapagos.
"Together with two other compounds in development, we have multiple
programs
capable of delivering in the immuno-inflammation alliance with GSK."
About Galapagos' immuno-inflammation alliance with GlaxoSmithKline
GSK and Galapagos initiated an alliance to discover and develop disease-
modifying drugs for GSK's global R&D organization in June 2006. GSK and
Galapagos expanded the alliance on three occasions to include additional
targets. Following the latest expansion in December 2009 and, subject to
achievement of milestones Galapagos has the potential to receive more than
EUR200
million, plus up to double-digit royalties from GSK. GSK has an exclusive
option to further develop and commercialize these compounds on a worldwide
basis. Since the start of the immuno-inflammation alliance, Galapagos has
received more than EUR60 million in payments from GSK.
About Galapagos
Galapagos (Euronext: GLPG) (PINKSHEETS: GLPYY) is a mid-size biotechnology
company
specialized in the discovery and development of small molecule and antibody
therapies with novel modes-of-action. The Company is progressing one of the
largest pipelines in biotech, with six programs in development and over 50
discovery programs. Through risk/reward-sharing alliances with
GlaxoSmithKline,
Lilly, Janssen Pharmaceutica, Roche and Servier, Galapagos is eligible to
receive up to EUR2.5 billion in downstream milestones, plus royalties. The
Galapagos Group has over 800 employees and operates facilities in seven
countries, with global headquarters in Mechelen, Belgium. More info at:
www.glpg.com
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Source: Galapagos NV via Thomson Reuters ONE
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