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
Galapagos NV (Euronext: GLPG) announced today
that it has started a Phase I Proof-of-Mechanism study for GLPG0492, a
drug for cachexia (loss of weight and muscle mass) and potentially
indications, such as Duchenne muscular dystrophy.
This Proof-of-Mechanism study follows the positive outcome of the first-in-
trial conducted for GLPG0492, which showed good safety and a
(PK) profile supporting once-daily oral dosing. The Proof-of-Mechanism
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
insight into the potential clinical benefits of a candidate drug," said
Wigerinck, SVP Development. "We aim to finalize this study by the end of
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
in at least 24 healthy volunteers using a once daily dosing regimen
weeks. The study will include early measurements of muscle
addition to Proof-of-Mechanism investigation, the safety,
pharmacokinetics of GLPG0492 will be assessed further.
About candidate drug GLPG0492 and cachexia
GLPG0492 is a fully proprietary, orally available small molecule that
has developed in its selective androgen receptor modulator (SARM)
pre-clinical studies, GLPG0492 has shown efficacy in the treatment of
the involuntary loss of weight and muscle mass which can affect patients
diseases such as cancer, chronic obstructive pulmonary disease (COPD) and
It is estimated that worldwide more than two million people die annually
the consequences of cancer-related cachexia. Galapagos aims for once-
oral dosing that improves muscle mass and function, with minimal
hormonal status in patients.
Candidate drug GLPG0492 has been shown to improve muscle mass and
animal models, with minimal cardiovascular, prostate, or virility side
traditionally seen with androgen therapies. In a Phase I study in
volunteers, GLPG0492 showed good safety and a PK profile which supports
daily oral dosing.
With the support of Charley's Fund and the Nash Avery Foundation, GLPG0492
was tested in a pre-clinical model of Duchenne muscular dystrophy; this
showed an improvement of muscle strength and running performance.
Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size biotechnology
specialized in the discovery and development of small molecule and
therapies with novel modes-of-action. The Company is progressing one
largest pipelines in biotech, with six programs in development and
discovery programs. Through risk/reward-sharing alliances with
Lilly, Janssen Pharmaceutica, Roche and Servier, Galapagos is
receive up to EUR2.5 billion in downstream milestones, plus
Galapagos Group has about 800 employees and operates facilities in
countries, with global headquarters in Mechelen, Belgium. More
This release may contain forward-looking statements, including,
limitation, statements containing the words "believes,"
"expects," "intends," "plans," "seeks," "estimates," "may," "will,"
"stands to," and "continues," as well as similar expressions. Such
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factors which might cause the actual results, financial condition,
or achievements of Galapagos, or industry results, to be materially
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these uncertainties, the reader is advised not to place any undue
such forward-looking statements. These forward-looking statements speak
of the date of publication of this document. Galapagos expressly
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required by law or regulation.
 Muscaritoli et al, Asia Pac J Clin Nutr 2008;17 (S1):387-390
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