Galapagos starts Phase 2 trial with GLPG1205 in ulcerative colitis patients
08 Janvier 2015 - 7:30AM
Mechelen,
Belgium; 8 January 2015 - Galapagos NV (Euronext: GLPG) announced
today it has initiated a Phase 2 Proof-of-Concept study in
ulcerative colitis with GPR84 inhibitor GLPG1205, a potential novel
treatment for Inflammatory Bowel Diseases. GLPG1205 arises
from Galapagos' target discovery platform and is fully proprietary
to Galapagos.
GLPG1205 ('1205) inhibits GPR84, a
novel mechanism of action developed by Galapagos for Inflammatory
Bowel Diseases (IBD). Galapagos has shown that GPR84 plays a
key role in IBD and that '1205 is a selective inhibitor of GPR84
and very effective in pre-clinical models for IBD. In Phase 1
studies, '1205 showed good safety, full blockage of GPR84, and
favorable drug-like properties. The first patients in this
double-blind, placebo controlled study will initiate their
treatment this week.
Details of the
Phase 2 clinical study
The clinical Proof-of-Concept Phase 2 trial for '1205 will involve
approximately 60 patients with moderate to severe ulcerative
colitis. The aim is to evaluate the efficacy, safety and
tolerability and pharmacokinetics of '1205, and to explore the
effects of '1205 on selected biomarkers in this patient population.
Patients will receive either 100 mg of '1205 or placebo (2:1
ratio) once-daily, for a period of twelve weeks. The primary
endpoint will be the change in Mayo scores versus baseline at 8
weeks, which includes endoscopic confirmation on improvement of
ulceration. This randomized, double-blind study will recruit
patients in multiple sites in 6 countries: Belgium, Hungary,
Poland, Czech Republic, Germany and Russia. Galapagos has received
full approvals to start the trial in Belgium, Hungary, Germany and
the Czech Republic, with patient recruitment already underway.
Approvals in Russia and Poland are expected to follow this first
quarter. The trial is anticipated to deliver top line data in
H1 2016.
About ulcerative
colitis
Ulcerative colitis (UC) is one of the 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
GPR84
G-coupled protein receptor 84 (GPR84) is involved in the regulation
of macrophages, monocytes, and neutrophils in the human immune
system. Galapagos identified GPR84 as playing a key role in
inflammation, using its proprietary target discovery platform.
GPR84 is over-expressed in patients with both forms of IBD -
UC and Crohn's disease - as well as in multiple sclerosis.
Galapagos has demonstrated in pre-clinical trials that GPR84
inhibition prevents neutrophil and macrophage chemotaxis induced by
specific triggers, and that '1205 prevents IBD disease progression
in animal models. '1205 is also the first selective
inhibitor of GPR84 to be tested in humans; it has shown good
safety, inhibition of GPR84, and favorable drug-like properties in
Phase 1 studies.
About
Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel
modes-of-action, with a large pipeline comprising three Phase 2
programs, two Phase 1 studies, five pre-clinical, and 25 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 an agreement for the development and
commercialization of GLPG0634. 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,
GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in
2012). GLPG1205, a first-in-class inhibitor of GPR84, is
currently being tested in a Phase 2 Proof-of-Concept study in
ulcerative colitis patients. GLPG1690 is a first-in-class
compound that targets pulmonary diseases and is currently in a
Phase 1 study. AbbVie and Galapagos signed an agreement in
cystic fibrosis to develop and commercialize molecules that address
mutations in the CFTR gene. Potentiator GLPG1837 started
Phase 1 last month, and corrector GLPG2222 is at the pre-clinical
candidate stage. The Galapagos Group, including
fee-for-service subsidiary Fidelta, has around 400 employees,
operating from its Mechelen, Belgium headquarters and facilities in
The Netherlands, France, and Croatia. Further information at:
www.glpg.com
CONTACT
Galapagos NV
Elizabeth Goodwin, Head of Corporate Communications &
IR
Tel: +31 6 2291 6240
ir@glpg.com
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Source: Galapagos NV via Globenewswire
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