gilead-sciences

Gilead and Galapagos’ ankylosing spondylitis drug hits Phase 2 trial goal

pharmafile | September 7, 2018 | News story | Medical Communications, Research and Development Galapagos, Gilead, ankylosing spondylitis, filgotinib, pharma 

Gilead and Galapagos have announced that their jointly-developed selective JAK1 inhibitor filgotinib has met its primary endpoint in a Phase 2 trial investigating its efficacy in the treatment of moderately to severely active ankylosing spondylitis (AS) in adult patients.

Specifically, the therapy was found to lead to “significantly greater improvements” in AS Disease Activity Score (ASDAS) – the trial’s primary endpoint – after 12 weeks of treatment; the mean change of -1.5 versus -0.6 for placebo, while 76% of patients taking filgotinib achieved an ASAS response of 20 compared to just 40% with placebo.

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

Dr Walid Abi-Saab, Chief Medical Officer at Galapagos, also added: “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.”

The pair of companies confirmed that detailed results of the study would be presented at an upcoming scientific conference.

Matt Fellows

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