Galapagos receives €7.4 M milestone in arthritis alliance with GlaxoSmithKline
Galapagos NV announced progress achieved in its arthritis alliance with GlaxoSmithKline (GSK). Galapagos completed first-in-human trials with GLPG0555 in healthy volunteers. Galapagos also initiated clinical Phase I development for a second candidate drug, GLPG0778, which triggered a milestone payment of €7.4 million.
Initial Phase I results for the first candidate drug in the alliance, GLPG0555, showed no changes in vital signs and laboratory parameters for dosing up to 14 consecutive days in healthy volunteers. GLPG0555 was well tolerated with no severe adverse events reported.
In late December 2010, Galapagos initiated a first-in-human trial for GLPG0778, which is being conducted in healthy volunteers over the coming months. This second candidate drug, which inhibits kinase target GT623, has demonstrated excellent activity and safety in biochemical and animal models, and has successfully completed pre-clinical development.
"We are pleased to report progress on candidate drugs in our arthritis alliance with GSK," said Onno van de Stolpe, CEO of Galapagos. "Today's announcement increases our clinical rheumatoid arthritis portfolio to four candidate drugs, with a balanced risk profile of known and novel modes of action."
The primary endpoints of the first-in-human trials were to determine the safety, tolerability and PK profile of candidate drug GLPG0555. The double-blind, single ascending and multiple dose studies were conducted in 35 healthy human volunteers.
A double-blind, multiple ascending dose study for GLPG0555 is currently being conducted in up to 40 healthy human volunteers to further assess the safety, PK and biomarker profile. Furthermore, Galapagos is preparing to investigate a novel capsule formulation for later stage trials.
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