Galapagos NV has announced that GLPG1205, a first-in-class molecule for inflammatory disorders, has demonstrated target engagement, a good safety profile, and favorable drug properties in a Phase 1 study. Galapagos is developing GLPG1205 within its alliance with Janssen Pharmaceutica NV.
The aim of the Phase 1 study was to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral single and multiple ascending doses of GLPG1205. The randomized, double-blind, placebo-controlled, single center study was conducted in 40 healthy volunteers in Belgium.
In the first part of the study, single ascending doses were evaluated. In the second part, the new compound was administered daily for 14 days.
GLPG1205 was safe and well-tolerated over a wide dose range in healthy volunteers. Engagement of the thus far undisclosed novel target was confirmed using a relevant biomarker.
GLPG1205 displayed a favorable pharmacokinetic and pharmacodynamic profile, potentially supporting once-daily dosing. The data shown in Phase 1 encourage Galapagos to progress GLPG1205 into a Phase 2A study in Inflammatory Bowel Disease (IBD).
"GLPG1205 is the first molecule against this target ever to be evaluated clinically, and we are pleased with the outcome of the Phase 1 study," said Piet Wigerinck, CSO of Galapagos. "Galapagos continues to deliver novel therapeutics from its unique target and drug discovery engine. GLPG1205 will be the fourth compound to enter Phase 2A in our portfolio of proprietary and partnered programs based on novel targets."
In 2007, Galapagos announced an alliance agreement with Janssen Pharmaceutica NV providing the option to worldwide, commercial licenses to certain Galapagos internal inflammatory disease programs.
These programs include a novel target for inflammatory disorders that was identified and validated by Galapagos using its proprietary target discovery engine.
Subsequent Galapagos research led to the discovery of GLPG1205, a first-in-class molecule that entered the clinic for inflammatory disorders. Galapagos is responsible for execution of Phase 1 and Phase 2A studies with GLPG1205.