Filgotinib, an investigational and selective JAK1 inhibitor, has achieved its primary efficacy endpoint in adults with moderately to severely active AS in the phase 2 Tortuga study.
AS is a systemic, chronic, and progressive seronegative spondyloarthritis, which affects the spine and sacroiliac (SI) joints and expected to advance to spinal fusion.
In the trial, patients treated with filgotinib achieved significant improvements in AS disease activity score (ASDAS), the primary endpoint, at week 12.
Gilead research and development head and chief scientific officer Dr John McHutchison said: “These data are encouraging, suggesting filgotinib has the potential to play an important role in addressing this medical need.”
Tortuga was a multi-center, randomized, double-blind, placebo-controlled and phase-2 trial designed to evaluate the safety and efficacy of filgotinib in adult patients with moderately to severely active AS.
The companies carried out the study at the centers in Belgium, Bulgaria, Czech Republic, Estonia, Poland, Spain and Ukraine.
The trial randomized116 patients in a 1:1 ratio to secure filgotinib 200mg or placebo once daily for 12 weeks.
Gilead collaborated with Galapagos for the development and commercialization of filgotinib in inflammatory indications.
The phase 2 Tortuga trial in ankylosing spondylitis is one of several phase 2 trials in inflammatory diseases, while the partnership is also involved in ongoing Finch phase 3 program in rheumatoid arthritis, the Diversity phase 3 trial in Crohn’s disease and the phase 3 Selection trial in ulcerative colitis.
Galapagos chief medical officer Dr Walid Abi-Saab said: “We are excited to see that filgotinib showed strong activity across a wide range of parameters relevant for ankylosing spondylitis and was well tolerated in TORTUGA, which reinforces previous findings about the activity and tolerability profile of filgotinib in multiple inflammatory conditions.”
Galapagos is engaged in the discovery and development of small molecule medicines with novel modes of action, while Gilead Sciences is involved in the discovery, development and commercialization of medicines in areas of unmet medical need.