MECHELEN, Belgium—Galapagos NV announced today that GLPG1690, a first-in-class molecule for pulmonary disease, has demonstrated target engagement, a good safety profile, and favorable drug properties in a Phase 1 study. Galapagos is developing GLPG1690 within its alliance with Janssen Pharmaceutica NV.
The aim of the Phase 1 study was to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral single and multiple ascending doses of GLPG1690. The randomized, double-blind, placebo-controlled, single center study was conducted in 40 healthy volunteers in Belgium. In the first part of the study, single ascending doses were evaluated. In the second part, the new compound was administered daily for 14 days.
GLPG1690 proved to be safe and well-tolerated over a wide dose range in healthy volunteers. Engagement of the thus far undisclosed novel target was confirmed using a relevant biomarker, the company stated in a release. GLPG1690 displayed a favorable pharmacokinetic and pharmacodynamic profile. The data shown in Phase 1 encourage Galapagos to explore a Phase 2 study design in pulmonary disease.
"GLPG1690 is the first molecule against this target ever to be evaluated clinically, and we are pleased with the outcome of the Phase 1 study," said Dr. Piet Wigerinck, CSO of Galapagos. "Galapagos continues to deliver novel therapeutics from its unique target and drug discovery engine."
In 2007, Galapagos announced an alliance agreement with Janssen Pharmaceutica NV providing the option to worldwide, commercial licenses to certain Galapagos internal inflammatory disease programs. These programs are based on novel targets for inflammatory disorders that were identified and validated by Galapagos using its proprietary target discovery engine. Subsequent Galapagos research led to the discovery of GLPG1690, a first-in-class molecule that entered the clinic for inflammatory disorders. Galapagos is responsible for execution of Phase 1 and Phase 2a studies with GLPG1690.
Galapagos is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action, with a pipeline comprising three Phase 2 programs, two Phase 1 trials, five pre-clinical studies, and 25 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, and other indications. In the field of inflammation, AbbVie and Galapagos signed a collaboration agreement for the development and commercialization of GLPG0634, an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and potentially other inflammatory diseases, currently in Phase 2b studies in RA and in Phase 2 in Crohn's disease. GLPG1205, a first-in-class inhibitor of GPR84, is currently being tested in a Phase 2 proof-of-concept trial in ulcerative colitis patients. GLPG1690 is a compound that targets pulmonary diseases and is currently in a Phase 1 trial. AbbVie and Galapagos also signed a collaboration agreement in cystic fibrosis to develop and commercialize molecules that address mutations in the CFTR gene. Potentiator GLPG1837 is currently in a Phase 1 trial, and corrector GLPG2222 is at the pre-clinical candidate stage.
The Phase 1 trial with GLPG1837, its investigational CFTR targeted therapy for patients with cystic fibrosis who carry class III/IV mutations.was launched in December 2014. The Belgium-based study will enroll 40 healthy volunteers and will evaluate the safety, tolerability and pharmacokinetics of oral single and multiple ascending doses of GLPG1837. Results are expected in H2 2015. The start of the trial triggered a $10M milestone payment from AbbVie.
The Galapagos Group, including fee-for-service subsidiary Fidelta, has approximately 400 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia.