MECHELEN, BELGIUM--(Marketwire - July 20, 2011) -
* Follows successful outcome of first-in-human clinical trial
* Proof-of-Mechanism study measures GLPG0492's effect on muscle function in
healthy volunteers
Galapagos NV (Euronext: GLPG) announced today
that it has started a Phase I Proof-of-Mechanism study for GLPG0492, a
candidate
drug for cachexia (loss of weight and muscle mass) and potentially
other
indications, such as Duchenne muscular dystrophy.
This Proof-of-Mechanism study follows the positive outcome of the first-in-
human
trial conducted for GLPG0492, which showed good safety and a
pharmacokinetic
(PK) profile supporting once-daily oral dosing. The Proof-of-Mechanism
study
aims to assess GLPG0492's effect on muscle function in healthy volunteers.
"This is the third time this year we initiate a clinical study designed to
give
insight into the potential clinical benefits of a candidate drug," said
Piet
Wigerinck, SVP Development. "We aim to finalize this study by the end of
2011
before further evaluating the compound in a patient population."
Details of the Phase I Proof-of-Mechanism study
Galapagos plans to conduct the placebo-controlled, multiple ascending dose
study
in at least 24 healthy volunteers using a once daily dosing regimen
for two
weeks. The study will include early measurements of muscle
function. In
addition to Proof-of-Mechanism investigation, the safety,
tolerability and
pharmacokinetics of GLPG0492 will be assessed further.
About candidate drug GLPG0492 and cachexia
GLPG0492 is a fully proprietary, orally available small molecule that
Galapagos
has developed in its selective androgen receptor modulator (SARM)
program. In
pre-clinical studies, GLPG0492 has shown efficacy in the treatment of
cachexia,
the involuntary loss of weight and muscle mass which can affect patients
with
diseases such as cancer, chronic obstructive pulmonary disease (COPD) and
AIDS.
It is estimated that worldwide more than two million people die annually
from
the consequences of cancer-related cachexia[1]. Galapagos aims for once-
a-day
oral dosing that improves muscle mass and function, with minimal
effects on
hormonal status in patients.
Candidate drug GLPG0492 has been shown to improve muscle mass and
function in
animal models, with minimal cardiovascular, prostate, or virility side
effects
traditionally seen with androgen therapies. In a Phase I study in
healthy
volunteers, GLPG0492 showed good safety and a PK profile which supports
once-
daily oral dosing.
With the support of Charley's Fund and the Nash Avery Foundation, GLPG0492
also
was tested in a pre-clinical model of Duchenne muscular dystrophy; this
test
showed an improvement of muscle strength and running performance.
About Galapagos
Galapagos (Euronext: GLPG; OTC: 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 about 800 employees and operates facilities in
six
countries, with global headquarters in Mechelen, Belgium. More
info at:
www.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 results, financial conditions,
performance or
achievements 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 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.
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[1] Muscaritoli et al, Asia Pac J Clin Nutr 2008;17 (S1):387-390
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