Galapagos to Advance Filgotinib to Phase 3 in Rheumatoid Arthritis

Galapagos NV has announced that the Company will be moving filgotinib, its highly selective JAK1 inhibitor, into Phase 3 in rheumatoid arthritis by early 2016. Filgotinib has shown best-in-class efficacy and safety in the DARWIN Phase 2B studies in rheumatoid arthritis and is now fully owned by Galapagos.

Galapagos has demonstrated that high selectivity for JAK1 results in excellent efficacy and safety in rheumatoid arthritis patients. Based on our own human whole blood assays comparing ABT-494 to filgotinib, filgotinib is three-fold more JAK1 selective than ABT-494. Galapagos reported best-in-class efficacy and safety in 24-week Phase 2B studies in 877 patients with filgotinib.

Furthermore, Galapagos has more than 700 patient-years of treatment experience with filgotinib in RA patients, of which more than 500 years at the highest 200 mg dose, all with a clean safety profile consistent with JAK1 inhitbition: filgotinib showed a clear dose dependent increase in hemoglobin concentration without any impact on NK cells and lymphocyte counts.

"We see a rapid path forward in development for filgotinib, which we will be taking into Phase 3. Galapagos is currently in advanced discussions with a substantial number of large pharma companies to partner filgotinib. We anticipate starting Phase 3 in rheumatoid arthritis with filgotinib early in 2016 and we are expecting data from our Phase 2B FITZROY study with filgotinib in Crohn's disease by year end," said Onno van de Stolpe, CEO of Galapagos.

On efficacy, Galapagos consistently has reported ACR scores using the most conservative NRI approach.