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news.Galapagos has begun Phase I first-in-human (FIH) study of a first-in-class molecule targeting inflammation of the bowel, GLPG1205 under research alliance with Janssen Pharmaceutica.
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According to the agreement signed in 2007, the commencement of the study triggered €6.6m milestone payment from Janssen to Galapagos, which will conduct even Phase IIA studies.
Designed to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic profile of oral single and multiple ascending doses of GLPG1205, the double-blind study will be conducted in 40 healthy volunteers in Belgium .
Galapagos CEO Onno van de Stolpe said another proprietary molecule with a novel mode-of-action, GLPG1205, was moved into the clinic.
"Consistent with our strategy of bringing innovative molecules to the clinic, this is the fourth First-in- Human study with a novel mode-of-action," Onno van de Stolpe added.
"Today’s achievement brings Galapagos’ pipeline to five clinical programs, and we are pleased we will be driving the Phase 1 and 2A studies forward with this potential new therapy in inflammatory disease."
The first part of the single centre study will assess single ascending doses of the investigational agent while the new compound will be administered daily for 14 days in the second part.
The topline results are expected by the end of 2013.