The initiation of the FIH study with GLPG1205 has triggered a €6.6m milestone payment from Janssen to Galapagos.

The first-in-human (FIH) study was designed to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic profile of oral single and multiple ascending doses of GLPG1205.

Galapagos CEO Onno van de Stolpe said that another proprietary GLPG1205 molecule with a novel mode-of-action was moved into the clinic.

"Consistent with our strategy of bringing innovative molecules to the clinic, this is the fourth FIH study with a novel mode-of-action," Onno van de Stolpe said.

"Today’s achievement brings Galapagos’s pipeline to five clinical programmes, and we are pleased we will be driving the Phase 1 and 2A studies forward with this potential new therapy in inflammatory disease," Onno van de Stolpe added.

Single ascending doses of the investigational agent will be evaluated in the first part of the single centre study, while the new compound will be administered daily for 14 days in the second part.

Conducted in 40 healthy volunteers in Belgium, the randomised, double-blind study’s topline results are expected by the end of 2013.

As per the agreement signed in 2007, Galapagos will execute Phase I and Phase IIA studies.

Image: Janssen Pharmaceutica unit in Xi’an. Photo: courtesy of Vberger.