Galapagos completes patient recruitment in Proof of Concept study with GLPG0974 in ulcerative colitis
February 17 2014 - 1:34AM
Galapagos NV (Euronext: GLPG) announced today that patient
recruitment has been completed for the clinical Proof of Concept
study with GLPG0974. GLPG0974 presents a novel mode of action for
the treatment of ulcerative colitis, a debilitating inflammatory
bowel disease. T he efficacy and safety of
GLPG0974 are being evaluated during a 28-day treatment
period. Topline results from this study are expected in June
2014. GLPG0974 is fully proprietary to Galapagos.
As a potent inhibitor of FFA2 (free fatty acid
receptor 2), GLPG0974 aims to reduce migration of neutrophils into
the gastro-intestinal tract. Over-activity of neutrophils
damages the bowel tissue and causes chronic inflammation in
ulcerative colitis. FFA2 plays an important role in the
migration of neutrophils and is over-expressed in ulcerative
colitis patients. In healthy volunteers, 14 days of once- or
twice-daily oral dosing of GLPG0974 was well-tolerated and safe up
to the highest doses tested. A sustained suppression of a
biomarker for neutrophil activation demonstrated the desired
pharmacodynamic activity.
Details of the Phase 2a clinical
study The clinical Proof-of-Concept Phase 2 trial for
GLPG0974 is designed to recruit 45 patients with mild to moderate
ulcerative colitis. The aim is to evaluate the safety,
efficacy, pharmacokinetics and effects on selected biomarkers of
GLPG0974 in this patient population. Patients are randomized
to receive either 200 mg of GLPG0974 twice-daily or placebo (2:1
ratio), for a period of 28 days. This double-blind,
placebo-controlled study recruited patients in multiple sites in 4
countries: Belgium, the Czech Republic, Latvia, and Slovakia.
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. Bacteria produce
free fatty acids by fermentation of food fibers in the gut.
These fatty acids attract neutrophils through the activation
of the neutrophil FFA2 receptor. 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.
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 comprising of six Phase 2
studies (three led by GSK), one Phase 1 study, six pre-clinical,
and 20 discovery small-molecule and antibody programs in cystic
fibrosis, inflammation, antibiotics, metabolic disease, and other
indications. In the field of inflammation, AbbVie and
Galapagos signed a worldwide license agreement whereby AbbVie will
be responsible for further development and commercialization of
GLPG0634 after Phase 2B. GLPG0634 is an orally-available,
selective inhibitor of JAK1 for the treatment of rheumatoid
arthritis and potentially other inflammatory diseases, currently in
Phase 2B studies in RA and in Phase 2 in Crohn's disease.
Galapagos has another selective JAK1 inhibitor in Phase 2 in
ulcerative colitis, psoriasis, and lupus, GSK2586184 (formerly
GLPG0778, in-licensed by GlaxoSmithKline in 2012). 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. GLPG1205 is a first-in-class molecule that
targets inflammatory disorders and has completed Phase 1.
AbbVie and Galapagos signed an agreement in CF where they
work collaboratively to develop and commercialize oral drugs that
address two mutations in the CFTR gene, the G551D and F508del
mutation. Potentiator GLPG1837 is at the pre-clinical
candidate stage. 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
For media and investor inquiries: Elizabeth
Goodwin, Head of Corporate Communications & Investor Relations
Tel: +31 6 2291 6240 ir@glpg.com
For business development inquiries: Andre
Hoekema, Senior VP Corporate Development Tel: +31 71 7506 700
bd@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.
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