Galapagos NV receives milestone payment to initiate Phase I clinical trial of GLPG0555 drug

Dec 8 2009

Galapagos NV (Euronext: GLPG) announced today that it has initiated clinical Phase I development of the first small molecule candidate from its arthritis alliance with GlaxoSmithKline (GSK). For entering the clinic with candidate drug GLPG0555, Galapagos receives a milestone payment of EUR 4 million cash from GSK. Since the start of the arthritis alliance in June 2006, Galapagos has received a total of EUR 35 million in payments from GSK.

The orally-available, novel candidate drug GLPG0555 modifies kinase target GT622 and was identified through Galapagos' proprietary target discovery platform. Candidate drug GLPG0555 has demonstrated excellent activity in biochemical and animal models and has successfully completed pre-clinical development.

"This alliance with GSK was Galapagos' first, adding a special significance to today's clinical milestone. By funding an alliance program from target discovery to Phase I through success-based payments, we are achieving what we set out to do with our alliance strategy. This trial marks the first of what we would hope to be many programs from the arthritis alliance with GSK to enter the clinic," said Onno van de Stolpe, Chief Executive Officer of Galapagos.

With the initiation of the Phase I trial with GLPG0555, Galapagos now has four candidate drugs in clinical development (Phase I and Phase II).

Details of the Phase I clinical trial

The primary endpoints of this first-in-human trial will be to determine the safety, tolerability, and pharmacokinetics of the candidate drug GLPG0555. The double blind, single ascending and multiple dose studies will be conducted in 34 healthy human volunteers in Belgium over the coming months.