Galapagos initiates Phase 3 program with filgotinib in patients with active axial spondyloarthritis

• OLINGUITO Phase 3 program in adults with axial spondyloarthritis (AxSpA) to include two parallel studies to investigate the efficacy and safety of filgotinib in patients with active radiographic AxSpA (r-AxSpA) and non-radiographic AxSpA (nr-AxSpA)

• Results from Phase 2 TORTUGA study showed that filgotinib 200mg was efficacious and well-tolerated in patients with r-AxSpA

• Filgotinib, an oral, once-daily JAK1 preferential inhibitor, is currently approved in Europe and Japan for the treatment of rheumatoid arthritis (RA) and ulcerative colitis (UC)

In the Phase 2 TORTUGA study, filgotinib 200mg achieved significantly greater improvements in Ankylosing Spondylitis Disease Activity Score (ASDAS) (1) at Week 12, the primary endpoint, and had an encouraging safety profile in patients with active r-AxSpA who had not responded to conventional treatment. (2)

“Axial spondyloarthritis is a chronic, painful, highly invalidating inflammatory condition that can profoundly impact patients’ quality of life,” said Prof. Xenofon Baraliakos, Professor of Internal Medicine and Rheumatology at Ruhr-University Bochum, Germany and Coordinating Investigator of the study. “There is a high unmet need for effective oral treatment options for this condition. I am pleased that the first trial sites have been initiated and look forward to continuing to work with Galapagos and with the other study sites to rapidly enroll patients in this pivotal trial.”

“Patients with AxSpA face a significant disease burden and given the limited available therapies, there remains a high unmet medical need for effective oral treatment options,” said Daniele D’Ambrosio, MD, PhD, Therapeutic Area Head, Immunology, at Galapagos. “Filgotinib has demonstrated a consistent efficacy and safety profile across a range of patient populations, and inflammatory conditions and has the potential to address the needs of patients living with AxSpA. We look forward to advancing the OLINGUITO program and to working collaboratively with our clinical partners.”

The OLINGUITO global Phase 3 program (NCT05785611) consists of two randomized, placebo-controlled, double-blind, multi-center, parallel-group studies. The objectives of the studies are to investigate the efficacy and safety of orally administered filgotinib for 16 weeks in 476 patients with active r-AxSpA (Study A) and nr-AxSpA (Study B) who have had an inadequate response to conventional or biological treatment. Each study will enroll approximately 238 patients who are randomized 1:1 to receive filgotinib 200mg or placebo once-daily. The primary endpoint for Study A and Study B is the proportion of patients who achieve an ASAS40 (3) response at Week 16 in compliance with the European Medicines Agency’s (EMA) guidelines. The double-blind studies will be followed by an open-label treatment period in which all patients will receive filgotinib 200mg once-daily up to Week 52. Patients from Study A and Study B who achieve sustained low disease activity in the open-label treatment period will be re-randomized 1:1 at Week 52 to receive double-blind filgotinib 100mg or 200mg up to Week 104.

(1) The Ankylosing Spondylitis Disease Activity Score (ASDAS) is an index to assess disease activity in Ankylosing Spondylitis (AS).

(2) Van Der Heijde D. Efficacy and safety of filgotinib, a selective Janus kinase 1 inhibitor, in patients with active ankylosing spondylitis (TORTUGA): results from a randomised, placebo-controlled, phase 2 trial Lancet 2018;392:2378-87.

(3) Percentage of Participants Achieving SpondyloArthritis International Society 40% improvement.