Mechelen, Belgium 17 November 2014: Galapagos NV (Euronext: GLPG), a clinical stage biotech company focused on developing novel mode of action medicines, announces that it will present data supporting the safe use and absence of drug-drug interactions of GLPG0634 (filgotinib) with drugs commonly prescribed for rheumatoid arthritis (RA) patients. In addition, Galapagos will show support for the dose selection in the Phase 2B DARWIN program and present the reversals of RA disease gene expression in patients treated with GLPG0634. These data will be presented at the ACR/ARHP Annual Meeting, November 14 – 19, in Boston, Massachusetts.
GLPG0634 is an orally-available, selective JAK1 inhibitor. Selective inhibition of JAK1 may combine favorable safety and clinical efficacy profiles with rapid onset of action. GLPG0634 is currently in a global Phase 2B program (DARWIN) in 875 RA patients and in a Phase 2 study in 180 patients with Crohn’s disease.
All three posters on GLPG0634 will be presented during the ACR poster session entitled: “Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy: Novel therapies, Biosimilars, Strategies and Mechanisms in Rheumatoid Arthritis,” from 9 – 11 AM EST on Monday, 17 November, 2014. The posters are also available on the Galapagos home page, www.glpg.com. Below are summaries of the key findings in each poster:
“Phase 1 and Phase 2 Data Confirm That GLPG0634, a Selective JAK1 Inhibitor, Has a Low Potential for Drug-Drug Interactions” Abstract #1481
In contrast to some other JAK inhibitors, GLPG0634 does not interact with CYP450s and drug transporters. In vitro data are confirmed by clinical data in healthy volunteers and RA patients showing that GLPG0634 does not inhibit neither induce CYP3A4 activity. GLPG0634 also shows no interaction with OAT transporters involved in methotrexate or statin excretion. Taken together, these data suggest that GLPG0634 can be used safely without dose adjustment in RA-patients treated with frequently co-administered drugs such as methotrexate and statins.
“Dose Selection of GLPG0634, a Selective JAK1 Inhibitor, for Rheumatoid Arthritis Phase 2B Studies: PK/PD and Exposure-DAS28 Modelling Approach” Abstract #1480
A PK/PD modelling analysis show that GLPG6034 and its main metabolite both contribute to the pSTAT1 biomarker response. A DAS28 clinical response model highlights a dose-response relation with a maximum efficacy achieved at a daily dose of 200 mg GLPG0634. No further gain is obtained at higher doses. The overall clinical response, as measured by DAS28, is in the range of that observed with registered biological DMARDS. A GLPG0634 daily dose range from 50 to 200 mg is currently being tested in the Phase 2B DARWIN program.
“Treatment of Rheumatoid Arthritis Patients with the JAK1-Selective Inhibitor GLPG0634 Reverses an Arthritis-Specific Blood Gene Signature to Healthy State” Abstract #1494
An RA-specific gene signature was found in circulating white blood cells. Treating RA patients with GLPG0634 was associated with a reversal of the gene expression, resulting in a gene signature similar to healthy volunteers. These data support the clinical efficacy observed in the phase 2A study and thus expand our knowledge of the effects of GLPG0634 in RA patients.
Galapagos (Euronext: GLPG; OTC: GLPYY) is specialized in novel modes-of-action, with a pipeline comprising three Phase 2 studies, two Phase 1 studies, five pre-clinical, and 20 discovery small-molecule and antibody programs in cystic fibrosis, inflammation, antibiotics and metabolic disease. In the field of inflammation, AbbVie and Galapagos signed an agreement for the development and commercialization of GLPG0634. GLPG0634 (filgotinib) is an orally-available, selective inhibitor of JAK1 for the treatment of rheumatoid arthritis and other inflammatory diseases, currently in Phase 2B studies in RA and in Phase 2 in Crohn’s disease. Galapagos has another selective JAK1 inhibitor, GSK2586184 (formerly GLPG0778, in-licensed by GlaxoSmithKline in 2012). AbbVie and Galapagos signed an agreement in cystic fibrosis to develop and commercialize molecules that address mutations in the CFTR gene. Potentiator GLPG1837 is expected to start Phase 1 in 2014. Galapagos also expects to nominate a pre-clinical candidate corrector before year end 2014. The Galapagos Group, including fee-for-service subsidiary Fidelta, has around 400 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. Further information at: www.glpg.com
Elizabeth Goodwin, Head of Corporate Communications & IR
Tel: +31 6 2291 6240
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