Gil Roth12.19.11
Galapagos' investigative drug GLPG0778 has shown selective effects on a biomarker in a Phase I Proof-of-Mechanism study in healthy volunteers. GPLG0778 showed dose-dependent, statistically-significant and selective suppression of an induced inflammatory response in volunteers, indicating specific inhibition of the medicine's target in vivo. The study also provided information on the safety and pharmacokinetic (PK) profile of GLPG0778.
GLPG0778 is part of Galapagos' immuno-inflammatory alliance with GlaxoSmithKline. The trial results, which included 45 healthy volunteers divided into five cohorts, receiving a total of four different dosages for two weeks, achieved GSK's criteria of clinical Proof of Mechanism, thereby triggering a multi-million dollar payment to Galapagos. GSK now has 90 days to evaluate these results and determine whether to exercise its exclusive option to in-license GLPG0778 and its corresponding back-up compounds, including GLPG0555.
"GLPG0778 is Galapagos' second candidate drug to show targeted activity in clinical trials this year and our first alliance program to deliver clinical Proof-of Mechanism results," said Onno van de Stolpe, chief executive officer of Galapagos. "We believe GLPG0778's biomarker and safety profile support its further development in a Phase II clinical study in a patient population."
Galapagos and GSK began their alliance to discover and develop disease- modifying drugs in June 2006. Subject to achievement of certain milestone events Galapagos has the potential to receive more than $270 million in total milestone payments, plus double-digit royalties from GSK. Since the start of the immuno-inflammation alliance, Galapagos has received more than $90 million in payments from GSK.
GLPG0778 is part of Galapagos' immuno-inflammatory alliance with GlaxoSmithKline. The trial results, which included 45 healthy volunteers divided into five cohorts, receiving a total of four different dosages for two weeks, achieved GSK's criteria of clinical Proof of Mechanism, thereby triggering a multi-million dollar payment to Galapagos. GSK now has 90 days to evaluate these results and determine whether to exercise its exclusive option to in-license GLPG0778 and its corresponding back-up compounds, including GLPG0555.
"GLPG0778 is Galapagos' second candidate drug to show targeted activity in clinical trials this year and our first alliance program to deliver clinical Proof-of Mechanism results," said Onno van de Stolpe, chief executive officer of Galapagos. "We believe GLPG0778's biomarker and safety profile support its further development in a Phase II clinical study in a patient population."
Galapagos and GSK began their alliance to discover and develop disease- modifying drugs in June 2006. Subject to achievement of certain milestone events Galapagos has the potential to receive more than $270 million in total milestone payments, plus double-digit royalties from GSK. Since the start of the immuno-inflammation alliance, Galapagos has received more than $90 million in payments from GSK.