Galapagos starts Phase 2 trial with GLPG1205 in ulcerative colitis patients
January 08 2015 - 1:38AM
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
Galapagos forward-looking statements 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.
HUG#1885174
Galapagos (EU:GLPG)
Historical Stock Chart
From Jun 2024 to Jul 2024
Galapagos (EU:GLPG)
Historical Stock Chart
From Jul 2023 to Jul 2024