Galapagos starts Phase 2A study with GLPG0974 in ulcerative colitis
(Thomson Reuters ONE) -
Mechelen, Belgium; 23 April 2013 - Galapagos NV (Euronext: GLPG) announced today
the start of the first Phase 2 clinical study with GLPG0974. This is the third
compound from Galapagos' pipeline to enter Phase 2 studies, and its first drug
for patients with gastro-intestinal inflammation. GLPG0974 presents a novel
mode of action for the treatment of ulcerative colitis, a debilitating
inflammatory bowel disease. The efficacy and safety of GLPG0974 will be tested
in a four-week study with 45 patients and will deliver topline results early
2014.
As a potent inhibitor of FFA2, oral treatment with GLPG0974 aims to reduce
migration of neutrophils into the gastro-intestinal tract. Excessive influx of
this type of white blood cells damages the bowel tissue and causes chronic
inflammation in ulcerative colitis. The start of the Phase 2 Proof-of-Concept
study follows the excellent Phase 1 results with GLPG0974. In healthy
volunteers, 2 weeks of once- or twice daily oral dosing was well-tolerated and
safe up to the highest doses tested. A sustained suppression of biomarkers for
neutrophil activation demonstrated the desired pharmacodynamic activity.
"We are very excited about the start of the Phase 2 study with GLPG0974. We
discovered the role of the FFA2 target in inflammatory diseases, and we
developed GLPG0974 as a drug to inhibit FFA2. With this clinical program, we
expand our scope from rheumatology to gastroenterology," said Dr Piet Wigerinck,
CSO of Galapagos. "GLPG0974 is the first FFA2 antagonist being evaluated
clinically, and we are looking forward to the results in ulcerative colitis
patients. If the drug shows efficacy in these patients, this will be an
important step, as there is currently no cure for this disease. We expect to
report the results of the study in early 2014."
Details of the Phase 2A clinical study
The clinical Proof-of-Concept Phase 2 trial for GLPG0974 will involve 45
patients with mild to moderate ulcerative colitis. The aim is to evaluate the
efficacy, effects on selected biomarkers, safety and tolerability and
pharmacokinetics of GLPG0974 in this patient population. Patients with mild to
moderate disease will receive either 200 mg of GLPG0974 twice-daily or placebo
(2:1 ratio), for a period of four weeks. This randomized, double-blind,
placebo-controlled study will recruit patients in multiple sites in 4 countries:
Belgium, Latvia, Czech Republic and Slovakia. Galapagos has already received
approvals to start the trial in Belgium, with patient recruitment starting this
month. The trial is anticipated to complete by year end and deliver top line
data by Q1 2014.
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). Over-
activity 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 report
results of the Proof of Concept in early 2014.
About ulcerative colitis
Ulcerative colitis (UC) is one of the idiopathic forms of inflammatory bowel
disease (IBD). It is a chronic, relapsing inflammatory disease of the colon,
characterized by ulcers in the colon and rectum. Symptoms may include abdominal
pain, malnutrition, and diarrhea, often bloody. Ulcerative colitis has a
prevalence of 200-250 cases per 100,000 individuals per year and a peak
incidence between the ages of 15 and 25 years. 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 25-30% of the patients will
require surgery to remove the inflamed parts of the bowels.
About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action,
with a large pipeline of four clinical, seven 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 is currently in a Proof-of-Concept Phase 2 study.
The Galapagos Group, including fee-for-service companies BioFocus, Argenta and
Fidelta, has around 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
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of the date of publication of this document. Galapagos expressly disclaims any
obligation to update any such forward-looking statements in this document to
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Galapagos starts Phase 2A study with GLPG0974 in ulcerative colitis:
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