Galapagos, a drug discovery and development company, has initiated Phase I clinical development of its candidate drug GLPG0259 for rheumatoid arthritis.
Galapagos said that the primary endpoints of this first-in-human trial will be to determine the safety, tolerability and pharmacokinetics of the candidate drug GLPG0259. The double blind, single ascending and multiple dose studies will be conducted in 34 healthy human volunteers in Belgium.
GLPG0259 is the first small molecule from the company’s target discovery platform to enter the clinic, said Galapagos. GLPG0259 targets protein kinase MAPKAPK5, which reportedly represents a new approach for the treatment of rheumatoid arthritis (RA). The US Patent Office has granted Galapagos patents on the use of this target for the discovery of RA drugs and on the chemical space around this candidate drug.
GLPG0259 is a compound in Galapagos’s internal RA program, which is part of an alliance with Janssen Pharmaceutica. Upon successful completion of a Phase IIa clinical trial for GLPG0259, Janssen has the exclusive option to license the program for E60 million, with further potential milestones to Galapagos of E776 million and double-digit royalties on global sales.
Onno Stolpe, CEO of Galapagos, said: Today’s entry into the clinic is a true landmark for Galapagos. This is the first candidate medicine based on our target platform to enter the clinic and I am extremely proud of our team who made this achievement possible. We moved this RA program from concept to clinic in less than five years. Furthermore, we possess a broad portfolio of programs that further solidifies our activity in this therapeutic area.