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news.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.
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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.
GLPG1205 (‘1205) inhibits GPR84, a novel mechanism of action for the treatment of inflammatory bowel diseases (IBD). GPR84 is upregulated in IBD patients. Galapagos has shown that ‘1205, a selective inhibitor of GPR84, is very effective in pre-clinical models for IBD. In Phase 1 studies, once-daily oral ‘1205 showed good safety, full blockage of GPR84, and favorable drug-like properties.
"We are pleased that recruitment for the ORIGIN study has gone so well, which means we can report topline results one quarter earlier than planned," said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos. "We look forward to finding out if this novel mode of action opens a new approach towards the treatment of ulcerative colitis patients."
Details of ORIGIN, the clinical Proof-of-Concept study in ulcerative colitis
The Proof-of-Concept Phase 2 trial for ‘1205 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.
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.
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 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.