MECHELEN, BELGIUM--(Marketwire - October 24, 2012) - Galapagos NV (EURONEXT BRUSSELS: GLPG)
today that it has started its second Phase I clinical study with
GPR43 inhibitor being developed to treat chronic, neutrophil-driven
conditions such as inflammatory bowel disease (IBD). In this clinical
the safety and tolerability of GLPG0974 will be evaluated for 2 weeks
healthy volunteers. Aim of the study is also to confirm the strong
signal and the once-daily (QD) dosing of the compound after 14 days.
the study are expected to be reported early next year.
"GLPG0974 is one of our novel mode-of-action compounds in clinical
The clear inhibition of biomarker CD11b and the clean safety profile seen
First-in-Human Phase I study looked promising, and this second Phase I
will provide us with valuable information about the drug's profile
multiple administration. Patients suffering from IBD are in need of
therapies which treat the root cause of the disease. GLPG0974 targets
which Galapagos has identified as playing a key role in IBD," said Dr
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,
(PK), and pharmacodynamics of oral multiple ascending doses of GLPG0974.
randomized, double-blind, placebo-controlled, single center study
conducted in 32 healthy volunteers in Belgium. The study is designed to
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
neutrophils, one of the critical cell types in inflammatory processes, by
inhibition of GPR43 (also known as FFA2). Overactivity of neutrophils
cause of tissue damage in illnesses such as inflammatory bowel disease, and
anti-inflammatory mechanism may provide for a novel treatment
GLPG0974 is the first inhibitor of GPR43 to be evaluated clinically.
intends to determine the Phase II clinical strategy before year end 2012.
Inflammatory bowel disease is a group of inflammatory conditions in the
intestine and colon, the main forms being Crohn's and ulcerative
Crohn's disease can affect the entire wall in any part of the
tract, while ulcerative colitis affects only the lining in the
rectum. Patients suffering from IBD conditions experience abdominal
vomiting, diarrhea, weight loss, and rectal bleeding, and may also have
outside the bowel, such as problems with skin, eyes, and liver.
0.8% of the European population and 0.7% of the North American
diagnosed annually with IBD. This chronic condition is without a medical
and commonly requires a lifetime of care. Current treatment includes
anti-inflammatory steroids and immuno-suppressive agents such as TNF
Each year in the United States, IBD accounts for more than 700,000
visits, 100,000 hospitalizations, and disability in 119,000 patients.
long term, up to 75% of patients with Crohn's disease and 25% of those
ulcerative colitis will require surgery.
Galapagos (EURONEXT BRUSSELS: GLPG) (PINKSHEETS: GLPYY) is a mid-size
biotechnology company specialized in the discovery and development of
molecule and antibody therapies with novel modes-of-action. The
progressing its JAK1 inhibitor GLPG0634, as well as one of the largest
in biotech, with four programs in development and over 30 discovery
The Galapagos Group has over 800 employees and operates facilities
countries, with global headquarters in Mechelen, Belgium. More
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 Sources: Wikipedia, CDC.gov
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