Galapagos Successfully Completes First Phase I Study for GLPG0259
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Galapagos NV announces the successful completion its first-in-human trial of the novel candidate drug GLPG0259 for rheumatoid arthritis (RA). The candidate drug showed good safety in healthy volunteers and pharmacokinetic (PK) profile thus far, which supports once-daily oral dosing.
GLPG0259 is a novel mechanism-of-action inhibitor of the protein kinase MAPKAPK5, which was discovered through Galapagos' target discovery platform and represents a new approach for the treatment of RA.
The goal of the first-in-human trial was to determine the safety, tolerability, and pharmacokinetics of the candidate drug GLPG0259. The double blind, single ascending and multiple dose study was conducted in 34 healthy volunteers in Belgium from March to May 2009.
The compound was administered up to five consecutive days and showed good safety, with no cardiovascular side effects. The desired PK profile obtained thus far supports once-daily oral dosing.
"We are encouraged by the positive outcome of the first human trial for a candidate drug derived from Galapagos' target discovery platform," said Onno van de Stolpe, CEO of Galapagos. "We are on track to complete the Phase I trials for GLPG0259 by the end of 2009. Furthermore, preparations are underway to start a Phase IIa study in 2010, where we will assess the efficacy of this novel mechanism of action candidate drug in treating RA patients."
GLPG0259 is a novel mechanism-of-action inhibitor of the protein kinase MAPKAPK5, which was discovered through Galapagos' target discovery platform and represents a new approach for the treatment of RA.
The goal of the first-in-human trial was to determine the safety, tolerability, and pharmacokinetics of the candidate drug GLPG0259. The double blind, single ascending and multiple dose study was conducted in 34 healthy volunteers in Belgium from March to May 2009.
The compound was administered up to five consecutive days and showed good safety, with no cardiovascular side effects. The desired PK profile obtained thus far supports once-daily oral dosing.
"We are encouraged by the positive outcome of the first human trial for a candidate drug derived from Galapagos' target discovery platform," said Onno van de Stolpe, CEO of Galapagos. "We are on track to complete the Phase I trials for GLPG0259 by the end of 2009. Furthermore, preparations are underway to start a Phase IIa study in 2010, where we will assess the efficacy of this novel mechanism of action candidate drug in treating RA patients."
