Galapagos initiates clinical studies with GLPG0492, a candidate drug
Mechelen, Belgium; 20 May 2010 – Galapagos NV (Euronext: GLPG) announced today
that it has initiated a first-in-human trial for GLPG0492, its candidate drug for
cachexia (loss of weight and muscle mass) and potentially other indications, such as
Duchenne muscular dystrophy.
GLPG0492 is an orally available small molecule that Galapagos has developed in its Selective
Androgen Receptor Modulator (SARM) program. The candidate drug has been shown to improve
muscle mass in animal models, with minimal cardiovascular, prostate, or virility side effects
traditionally seen in androgen therapies. With the support of two foundations – Charley’s Fund
and the Nash Avery Foundation – Galapagos is currently evaluating the potential effectiveness of
GLPG0492 in pre-clinical models of Duchenne muscular dystrophy.
“GLPG0492 marks the fifth candidate drug to enter the clinic for Galapagos, since initiating our
first clinical trial in March 2009,” said Onno van de Stolpe, CEO of Galapagos. “GLPG0492 has
demonstrated an improvement in muscle mass in pre-clinical studies and therefore has the
potential to be efficacious in treating diseases where loss of muscle mass is severe, such as
cachexia and Duchenne.”
Details of the Phase I clinical trial
The primary endpoints of this first-in-human trial will be to determine the safety, tolerability and
pharmacokinetics of the candidate drug GLPG0492. The double-blind, single ascending dose
study will be conducted in 16 healthy human volunteers in Belgium over the coming months, with
results expected in the second half of 2010.
GLPG0492 binds with very high selectivity and affinity to targeted androgen receptors, potentially
enabling the candidate drug to be efficacious without cardiovascular, prostate, or virility side
effects traditionally seen in androgen therapies. Galapagos aims for once-a-day oral dosing that
improves muscle mass and function, with minimal effects on hormonal status in patients. In preclinical studies, GLPG0492 has shown efficacy in the treatment of cachexia, while pre-clinical
studies to evaluate the molecule’s potential efficacy in Duchenne muscular dystrophy are ongoing.
GLPG0492 is one of Galapagos’ unpartnered R&D programs which address known drug targets.
This portfolio of fully-owned programs also includes GLPG0187 being developed for cancer
metastasis and Nanocort© for acute flares in inflammatory diseases.
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 four clinical and over 50
small molecule discovery/pre-clinical programs. Through risk/reward-sharing alliances with
GlaxoSmithKline, Lilly, Janssen Pharmaceutica, Merck & Co. and Roche, Galapagos is eligible to
receive up to €3 billion in downstream milestones, plus royalties. Together with its BioFocus and
Argenta service operations, Galapagos has over 670 employees and operates facilities in six
countries, with global headquarters in Mechelen, Belgium. More info at: www.glpg.com
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
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 forwardlooking 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