Galapagos NV has announced positive results from the first in-human trials for the novel drug candidate GLPG0259 for use in patients suffering from rheumatoid arthritis (RA).
The candidate drug showed good safety record as well as an excellent pharmacokinetic profile, which supports once-daily oral dosing.
The treatment is a new approach to treating RA, through a novel mechanism-of-action inhibitor of the protein kinase MAPKAPK5, which was discovered through Galapagos’ target discovery platform.
Galapagos CEO Onno van de Stolpe said that the results were encouraging.
“We are on track to completing 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 drug,” van de Stolpe said.
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 on up to five consecutive days and showed good safety, with no cardiovascular side effects.
The compound has been developed as part of an internal RA programme, which is part of an option agreement with Janssen Pharmaceutica.
On completion of a dose-finding Phase II clinical trial for GLPG0259, Janssen has the exclusive option to license the programme for €60m, with further potential milestones to Galapagos of €776m and royalties on global sales.