Galapagos to start Phase 2a study with GLPG0974 in IBD patients
(Thomson Reuters ONE) -
* Positive Phase 1 study showed clean safety data and strong response of
biomarker
* Phase 2a Proof of Concept study in ulcerative colitis will start next month
Mechelen, Belgium; 27 March 2013 - Galapagos NV (Euronext: GLPG) announced today
that GLPG0974, an inhibitor of FFA2 (free fatty acid receptor 2, formerly known
as GPR43) being developed to treat chronic neutrophil-driven inflammatory
conditions such as inflammatory bowel disease (IBD), showed a clean safety
profile and a strong biomarker signal. In this second Phase 1 study with
GLPG0974, the safety, tolerability, pharmacodynamics and pharmacokinetics were
evaluated in 32 healthy volunteers dosed for 2 weeks. The positive outcome of
this study supports progression to a Proof of Concept study in ulcerative
colitis patients that is expected to start in 2Q 2013.
The completed Phase 1 study evaluated once- and twice-daily dosing regimens in
healthy volunteers who received GLPG0974 for 2 weeks. This second Phase 1 study
follows the First-in-Human study for GLPG0974 completed in 2012, in which a dose
range was given as single doses. The current study confirmed that GLPG0974 was
safe and well tolerated at all dose levels. A dose dependent inhibition of
neutrophil activation was shown, up to a maintained 24-hour inhibition of the
biomarker.
"GLPG0974 is the first FFA2 inhibitor to be tested clinically, and these results
are very encouraging," said Dr Piet Wigerinck, CSO of Galapagos. "The multiple
ascending dose study showed stable PK, good safety and tolerability and a good
inhibition of biomarker CD11b. The next step is a Proof of Concept study with
GLPG0974. The aim of this study will be to show a clinical response in patients
with ulcerative colitis. It is expected to start next month."
Details of the second Phase 1 clinical study
The aim of this study was to evaluate the safety, tolerability, pharmacokinetics
(PK), and pharmacodynamics (PD) of oral multiple ascending doses of GLPG0974.
The randomized, double-blind, placebo-controlled, single center study was
conducted in 32 healthy volunteers in Belgium. GLPG0974 was dosed for 2 weeks
as once- and twice-daily regimens. The study was designed to confirm the strong
biomarker signal previously observed in the First-in-Human Phase 1 study. The
biomarker that was measured in blood from healthy volunteers was CD11b, a
neutrophil surface marker. The presence of CD11b increases when neutrophils are
activated in response to inflammatory stimuli.
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 FFA2 (free fatty acid receptor 2, formerly known as GPR43).
Overactivity of neutrophils is a cause of tissue damage in illnesses such as
inflammatory bowel disease. A reduction of neutrophil activation and migration
by inhibition of FFA2 may provide for a novel anti-inflammatory treatment
approach. By inhibiting FFA2, GLPG0974 prevents free fatty acid-induced
activation and migration of neutrophils towards an inflammatory site, such as in
the gut of patients with inflammatory bowel disease. GLPG0974 is the first
inhibitor of FFA2 to be evaluated clinically. Galapagos expects to start a
Proof of Concept study ulcerative colitis in 2Q 2013.
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 drug treatment includes anti-
inflammatory steroids and immuno-suppressive agents such as TNF inhibitors.
Over the long term, up to 75% of patients with Crohn's disease and 25% of those
with ulcerative colitis will require surgery to remove the inflamed parts of the
bowels. In the United States, IBD accounts for more than 700,000 physician
visits and 100,000 hospitalizations per year, and disability in 119,000
patients.
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action,
with a large pipeline of four clinical, six pre-clinical, and 30 discovery
small-molecule and antibody programs in cystic fibrosis, inflammation,
antibiotics, metabolic disease, and other indications.
GLPG0634 is an orally-available, selective inhibitor of JAK1 for the treatment
of rheumatoid arthritis and potentially other inflammatory diseases, about to
enter Phase 2b studies. AbbVie and Galapagos signed a worldwide license
agreement whereby AbbVie will be responsible for further development and
commercialization after Phase 2b. Galapagos has another selective JAK1
inhibitor in Phase 2 in lupus and psoriasis, GSK2586184 (formerly GLPG0778, in-
licensed by GlaxoSmithKline in 2012). GLPG0187 is a novel integrin receptor
antagonist currently in a Phase 1b patient study in metastasis. GLPG0974 is the
first inhibitor of FFA2 to be evaluated clinically for the treatment of IBD;
this program will start a Proof of Concept Phase 2 study in Q2 2013.
The Galapagos Group, including fee-for-service companies BioFocus, Argenta and
Fidelta, has over 800 employees and operates facilities in five countries, with
global headquarters in Mechelen, Belgium. Further information at: www.glpg.com
CONTACT
Galapagos NV
Dr Piet Wigerinck, Chief Scientific Officer
Tel. +32 477 627103
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.
--------------------------------------------------------------------------------
[1] Sources: Wikipedia, CDC.gov
Galapagos to start Phase 2a study with GLPG0974 in IBD patients:
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