Mechelen, Belgium; 4 December 2013 – Galapagos NV (Euronext: GLPG) announced today that GLPG1205, a first-in-class molecule for inflammatory disorders, has demonstrated target engagement, a good safety profile, and favorable drug properties in a Phase 1 study. Galapagos is developing GLPG1205 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 GLPG1205. 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.
GLPG1205 was 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. GLPG1205 displayed a favorable pharmacokinetic and pharmacodynamic profile, potentially supporting once-daily dosing. The data shown in Phase 1 encourage Galapagos to progress GLPG1205 into a Phase 2A study in Inflammatory Bowel Disease (IBD).
“GLPG1205 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 Piet Wigerinck, CSO of Galapagos. “Galapagos continues to deliver novel therapeutics from its unique target and drug discovery engine. GLPG1205 will be the fourth compound to enter Phase 2A in our portfolio of proprietary and partnered programs based on novel targets.”
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 include a novel target for inflammatory disorders that was identified and validated by Galapagos using its proprietary target discovery engine. Subsequent Galapagos research led to the discovery of GLPG1205, 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 GLPG1205.
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action, with a large pipeline comprising of six Phase 2 studies (three led by GSK), one Phase 1 study, five pre-clinical, and 20 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics, metabolic disease, and other indications.
AbbVie and Galapagos signed an agreement in CF where they work collaboratively to develop and commercialize oral drugs that address two mutations in the CFTR gene, the G551D and F508del mutation. In the field of inflammation, AbbVie and Galapagos signed a worldwide license agreement whereby AbbVie will be responsible for further development and commercialization of GLPG0634 after Phase 2B. GLPG0634 is 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 about to enter Phase 2 studies in Crohn’s disease. Galapagos has another selective JAK1 inhibitor in Phase 2 in ulcerative colitis, psoriasis, and lupus, GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in 2012). GLPG0974 is the first inhibitor of FFA2 to be evaluated clinically for the treatment of IBD; this program is currently in a Proof-of-Concept Phase 2 study. GLPG1205, a first-in-class molecule that targets inflammatory disorders, has completed Phase 1 studies.
The Galapagos Group, including fee-for-service companies BioFocus, Argenta and Fidelta, has around 800 employees and operates facilities in five countries, with global headquarters in Mechelen, Belgium. Further information at: www.glpg.com
Piet Wigerinck, CSO
Tel: +32 477 62 7103
Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
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