Gilead and Galapagos announce TORTUGA Phase 2 Study of Filgotinib

Gilead Sciences, Inc. and Galapagos NV (Euronext & NASDAQ:GLPG) 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. For information about the clinical trials with filgotinib: www.clinicaltrials.gov.

TORTUGA was a multi-center, randomized, double-blind, placebo-controlled, Phase 2 study to assess the safety and efficacy of filgotinib in adult patients with moderately to severely active AS. The trial was conducted in Belgium, Bulgaria, Czech Republic, Estonia, Poland, Spain and Ukraine. In total, 116 patients were randomized in a 1:1 ratio to receive filgotinib 200 mg or placebo once daily for 12 weeks.

The primary objective of TORTUGA was to evaluate the effect of filgotinib compared to placebo on the signs and symptoms of AS, as assessed at Week 12 by ASDAS (a standard composite index for assessing the disease, which incorporates five disease activity variables).

AS is a systemic, chronic, and progressive seronegative spondyloarthritis that classically affects the spine and sacroiliac (SI) joints and may progress to spinal fusion, leading to permanent disability. Currently, there is no known cure for AS, but there are treatments and medications available to reduce signs and symptoms and manage pain.

Galapagos and Gilead entered into a global collaboration 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 in addition to the ongoing FINCH Phase 3 program in rheumatoid arthritis, the DIVERSITY Phase 3 trial in Crohn’s disease (also small bowel and fistulizing Crohn’s disease Phase 2 studies) and the Phase 3 SELECTION trial in ulcerative colitis.