Gilead and Galapagos Announce TORTUGA Phase 2 Study of Filgotinib in Ankylosing Spondylitis Achieves Primary Endpoint

Gilead Sciences and Galapagos announced that the randomized, placebo-controlled Phase 2 TORTUGA study of filgotinib, an investigational, selective JAK1 inhibitor, achieved its primary efficacy endpoint in adults with moderately to severely active ankylosing spondylitis (AS). In the study, patients treated with filgotinib achieved significantly greater improvements in AS Disease Activity Score (ASDAS), the primary endpoint, at Week 12, with a mean change from baseline of -1.5 versus -0.6 for those treated with placebo (p<0.0001). More patients receiving filgotinib also achieved an ASAS20 response compared to those treated with placebo (76 percent versus 40 percent, p<0.0001).

“People with ankylosing spondylitis face serious pain and disability, and, too often, their disease does not respond adequately to existing therapies,” said John McHutchison, MD, Chief Scientific Officer, Head of Research and Development, Gilead. “These data are encouraging, suggesting filgotinib has the potential to play an important role in addressing this medical need.”

“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,” said Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos.

Adverse events were generally mild or moderate in severity and were reported in an equal proportion of patients in the filgotinib and placebo groups. Laboratory changes were consistent with those previously reported for filgotinib, and no new safety signals were observed in the study. There was one treatment-emergent serious adverse event reported for a patient receiving filgotinib who experienced pneumonia and recovered after hospital-based antibiotic treatment. One patient randomized to filgotinib, with an inherited risk for thrombosis, experienced a non-serious deep venous thrombosis after completing the course of study drug. No deaths, malignancies, hepatic events, opportunistic infections or cases of Herpes zoster were observed in the study.

Detailed results from the TORTUGA trial will be submitted for presentation at a future scientific conference.

Filgotinib is investigational and not approved anywhere globally. Its efficacy and safety have not been established.