Filgotinib is a highly selective JAK1 inhibitor, discovered and developed by Galapagos using its target and drug discovery technology platform. In more than 1,600 patient years of rheumatoid arthritis (RA) and Crohn's disease clinical study experience, filgotinib has shown a rapid onset of action, potentially best-in-class efficacy and favorable findings on safety and tolerability. From a regulatory perspective, filgotinib is an investigational agent and its safety and efficacy have not been established.
Phase 3 programs with filgotinib in rheumatoid arthritis, Crohn's disease and ulcerative colitis (UC) were initiated in 2016, as well as Phase 2 studies in small bowel CD, fistulizing CD, Sjögren’s syndrome, ankylosing spondylitis, psoriatic arthritis, cutaneous lupus erythematosus (CLE), lupus membranous nephropathy and uveitis in 2017.
On 28 March 2019, Gilead and Galapagos announced that the Phase 3 FINCH 1 and FINCH 3 trials in RA patients refractory to methotrexate and naïve to methotrexate, respectively, met the primary and key secondary endpoints, with favorable safety data at the 24 week cutoff in line with FINCH 2 and previous studies with filgotinib. FINCH 1 and FINCH 3 are ongoing 52-week studies. On 12 September 2018, Gilead and Galapagos announced that the Phase 3 FINCH 2 trial in RA patients refractory to biologics met the primary and all key secondary endpoints, with favorable safety data in line with previous studies.
On 6 September 2018, Gilead and Galapagos announced that the TORTUGA Phase 2 trial of filgotinib in ankylosing spondylitis met the primary endpoint, with favorable safety data. The results from TORTUGA were published in The Lancet.
On 30 May 2018, Gilead and Galapagos announced that the EQUATOR Phase 2 trial of filgotinib in psoriatic arthritis met the primary endpoint, with favorable safety data. The results from EQUATOR were published in The Lancet. Gilead and Galapagos announced that the Phase 2b/3 SELECTION trial with filgotinib in ulcerative colitis progressed into Phase 3 following an interim futility analysis in which the DMC recommended that the study proceed as planned at both the 100 mg and 200 mg once daily dose level in biologic-experienced and biologic-naïve patients.