MECHELEN, BELGIUM--(Marketwire - October 24, 2012) - Galapagos NV (EURONEXT BRUSSELS: GLPG)
announced
today that it has started its second Phase I clinical study with
GLPG0974, a
GPR43 inhibitor being developed to treat chronic, neutrophil-driven
inflammatory
conditions such as inflammatory bowel disease (IBD). In this clinical
study,
the safety and tolerability of GLPG0974 will be evaluated for 2 weeks
in 32
healthy volunteers. Aim of the study is also to confirm the strong
biomarker
signal and the once-daily (QD) dosing of the compound after 14 days.
Results of
the study are expected to be reported early next year.
"GLPG0974 is one of our novel mode-of-action compounds in clinical
development.
The clear inhibition of biomarker CD11b and the clean safety profile seen
in the
First-in-Human Phase I study looked promising, and this second Phase I
study
will provide us with valuable information about the drug's profile
after
multiple administration. Patients suffering from IBD are in need of
effective
therapies which treat the root cause of the disease. GLPG0974 targets
GPR43,
which Galapagos has identified as playing a key role in IBD," said Dr
Piet
Wigerinck, Chief Scientific Officer of Galapagos.
Details of the second Phase I clinical study
The aim of this study is to evaluate the safety, tolerability,
pharmacokinetics
(PK), and pharmacodynamics of oral multiple ascending doses of GLPG0974.
The
randomized, double-blind, placebo-controlled, single center study
will be
conducted in 32 healthy volunteers in Belgium. The study is designed to
confirm
the strong biomarker signal and QD dosing possibilities observed in the
First-in-Human Phase I study.
About candidate drug GLPG0974
GLPG0974 is an orally available small molecule that reduces
migration of
neutrophils, one of the critical cell types in inflammatory processes, by
potent
inhibition of GPR43 (also known as FFA2). Overactivity of neutrophils
is a
cause of tissue damage in illnesses such as inflammatory bowel disease, and
this
anti-inflammatory mechanism may provide for a novel treatment
approach.
GLPG0974 is the first inhibitor of GPR43 to be evaluated clinically.
Galapagos
intends to determine the Phase II clinical strategy before year end 2012.
About IBD[1]
Inflammatory bowel disease is a group of inflammatory conditions in the
small
intestine and colon, the main forms being Crohn's and ulcerative
colitis.
Crohn's disease can affect the entire wall in any part of the
gastrointestinal
tract, while ulcerative colitis affects only the lining in the
colon and
rectum. Patients suffering from IBD conditions experience abdominal
pain,
vomiting, diarrhea, weight loss, and rectal bleeding, and may also have
symptoms
outside the bowel, such as problems with skin, eyes, and liver.
Approximately
0.8% of the European population and 0.7% of the North American
population is
diagnosed annually with IBD. This chronic condition is without a medical
cure
and commonly requires a lifetime of care. Current treatment includes
anti-inflammatory steroids and immuno-suppressive agents such as TNF
inhibitors.
Each year in the United States, IBD accounts for more than 700,000
physician
visits, 100,000 hospitalizations, and disability in 119,000 patients.
Over the
long term, up to 75% of patients with Crohn's disease and 25% of those
with
ulcerative colitis will require surgery.
About Galapagos
Galapagos (EURONEXT BRUSSELS: GLPG) (PINKSHEETS: GLPYY) is a mid-size
clinical stage
biotechnology company specialized in the discovery and development of
small
molecule and antibody therapies with novel modes-of-action. The
Company is
progressing its JAK1 inhibitor GLPG0634, as well as one of the largest
pipelines
in biotech, with four programs in development and over 30 discovery
programs.
The Galapagos Group has over 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,"
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[1] Sources: Wikipedia, CDC.gov
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