Belgian clinical stage biotech firm Galapagos has reported positive results from its Phase I trial of its first-in-class molecule, GLPG1690, for the treatment of patients with pulmonary disease.
GLPG1690 is being developed by the company in collaboration with Janssen Pharmaceutica.
The trial was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral single and multiple ascending doses of GLPG1690 in 40 healthy volunteers.
In the first part of the trial, single ascending doses were evaluated, while in the second part, the new compound was administered daily for 14 days.
In the randomised, double-blind, placebo-controlled, single centre trial, GLPG1690 proved to be safe and well-tolerated over a wide dose range in healthy volunteers.
In the trial, GLPG1690 displayed a favourable pharmacokinetic and pharmacodynamic profile and this data encourages the company to explore a Phase II trial design in pulmonary disease.
Galapagos CSO Dr Piet Wigerinck said: "GLPG1690 is the first molecule against this target ever to be evaluated clinically, and we are pleased with the outcome of the Phase I study.
"Galapagos continues to deliver novel therapeutics from its unique target and drug discovery engine."
In 2007, Galapagos entered into an agreement with Janssen Pharmaceutica providing the option to worldwide, commercial licenses to certain Galapagos internal inflammatory disease programs, which are based on new targets for inflammatory disorders.
These inflammatory disorders were identified and validated by Galapagos using its target discovery engine.
Galapagos specialises in the discovery and development of small molecule medicines with new modes of action, with a pipeline comprising three Phase II programmes, two Phase I trials, five pre-clinical studies, and 25 discovery small-molecule and antibody programmes in cystic fibrosis, inflammation, and other indications.
AbbVie and Galapagos have also signed a collaboration agreement to develop and commercialise GLPG0634, an orally-available, selective inhibitor of JAK1 to treat rheumatoid arthritis and potentially other inflammatory diseases, currently in Phase IIb trials in RA and in Phase II in Crohn's disease.