Date: 2012-10-24
Type of information:
phase: 1
Announcement: initiation
Company: Galapagos (Belgium)
Product: GLPG0974
Action mechanism: GLPG0974 is an orally available small molecule, nanomolar inhibitor of GPR43 (G-protein coupled receptor), also known as FFAR2 (free fatty acid receptor 2), which was identified by Galapagos as playing a key role in inflammation. GLPG0974 has shown potent inhibition of neutrophil migration (HOW) and successfully passed single dose animal safety evaluation. No other inhibitors of GPR43 are currently known to have been evaluated clinically.
Disease: inflammatory bowel disease (IBD)
Therapeutic area: Inflammatory diseases
Country: Belgium
Trial details: The aim of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of oral multiple ascending doses of GLPG0974. The randomized, double-blind, placebo-controlled, single center study will be conducted in 32 healthy volunteers in Belgium. The study is designed to confirm the strong biomarker signal and QD dosing possibilities observed in the First-in-Human Phase I study.
Latest
news: Galapagos has started its second Phase I clinical study with GLPG0974, a GPR43 inhibitor being developed to treat chronic neutrophil-driven inflammatory conditions such as inflammatory bowel disease (IBD). A first clinical study has been initiated in December 2011. In this second clinical study, the safety and tolerability of GLPG0974 will be evaluated for 2 weeks in 32 healthy volunteers. Aim of the study is also to confirm the strong biomarker signal and the once-daily (QD) dosing of the compound after 14 days. Results of the study are expected to be reported early next year. Galapagos intends to determine the Phase II clinical strategy before year end 2012.
