Date: 2016-01-26
Type of information: Results
phase: 2
Announcement: results
Company: Galapagos (Belgium)
Product: GLPG1205
Action
mechanism: GPCR inhibitor. GLPG1205 inhibits G-coupled protein receptor 84 (GPR84). 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.
Disease: moderate to severe ulcerative colitis
Therapeutic area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Country: Belgium, Czech Republic, Germany, Hungary, Poland, Russian Federation
Trial
details: The Proof-of-Concept Phase 2 trial (ORIGIN) for'GLPG1205 was initiated in January 2015 and involves approximately 60 patients with moderate to severe ulcerative colitis. The aim is to evaluate the efficacy, safety, tolerability and pharmacokinetics of '1205, and to explore the effects of '1205 on selected biomarkers in this patient population. Patients receive oral doses of either 100 mg of '1205 or placebo (2:1 ratio) once-daily, for a period of twelve weeks. The primary endpoint is the change in Mayo scores versus baseline after 8 weeks of treatment, which includes endoscopic confirmation on improvement of ulceration. This randomized, double-blind study recruited patients in multiple sites in 6 countries: Belgium, Czech Republic, Germany, Hungary, Poland, and Russia. The trial will deliver top line data in Q1 2016. (NCT02337608)
Latest
news: * On January 26, 2016, Galapagos announced that the ORIGIN Phase 2a study with GLPG1205 confirmed good pharmacokinetics, safety and tolerability. The endpoints for efficacy of GLPG1205 in patients with ulcerative colitis (UC), however, were not met. Galapagos will discontinue clinical development in ulcerative colitis. The ORIGIN study results showed that GLPG1205 did not statistically significantly differentiate from placebo on (partial) Mayo scores. GLPG1205 was shown to be overall safe and well-tolerated by patients in the ORIGIN study; exposure data were in line with the healthy volunteer data from the previous Phase 1 clinical study. Further details about the ORIGIN study will be published later during 2016. Galapagos will evaluate whether GLPG1205 will be developed in alternative indications. * On June 18, 2015, Galapagos announced it has completed recruitment for the Phase 2 Proof-of-Concept study in ulcerative colitis with GPR84 inhibitor GLPG1205, a potential novel treatment for inflammatory bowel diseases. Topline results from this study are now expected in Q1 2016. GPR84 was identified as a target for these diseases through Galapagos' target discovery platform and GLPG1205 is fully proprietary to Galapagos. * On January 8, 2015, Galapagos announced 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.The clinical Proof-of-Concept Phase 2 trial for GLPG1205 will involve approximately 60 patients with moderate to severe ulcerative colitis. The aim is to evaluate the efficacy, safety and tolerability and pharmacokinetics of GLPG1205, and to explore the effects of GLPG1205 on selected biomarkers in this patient population. Patients will receive either 100 mg of GLPG1205 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. The first patients in this double-blind, placebo controlled study will initiate their treatment this week.
