Galapagos initiates clinical studies with GLPG0492, a candidate drug for cachexia
(Thomson Reuters ONE) -
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.
About GLPG0492
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 pre-clinical 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 on-going.
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.
About Galapagos
Galapagos
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
CONTACT
Galapagos NV
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028
ir(at)glpg.com
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
ir(at)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.
[HUG#1417407]
Unternehmensinformation / Kurzprofil:
Datum: 20.05.2010 - 07:31 Uhr
Sprache: Deutsch
News-ID 21189
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