Gilead and Galapagos have unveiled another set of promising data for JAK inhibitor filgotinib, this time in rheumatoid arthritis.
Just days after reporting a Phase II success for the drug in ankylosing spondylitis, the firms said a Phase III trial also met its primary target in patients with rheumatoid arthritis who had previously failed to respond to treatment with or are intolerant to biologic agentes.
In the FINCH 2 study, a significantly greater proportion of patients receiving filgotinib achieved an American College of Rheumatology 20 percent response (ACR20) at Week 12 compared to placebo, with results of 66% (200mg dose) and 57.5% (100mg dose) versus 31%, respectively.
Also, at Weeks 12 and 24, the proportion of patients achieving ACR50 and ACR70, low disease activity, and clinical remission were significantly higher for patients receiving once-daily filgotinib 100mg or 200mg compared to patients receiving placebo, the firms noted.
On the safety side, the drug was reportedly found to be well tolerated, with treatment-emergent adverse events and serious adverse events “mostly mild or moderate in severity”. Serious adverse events occurred in 3.4%, 5.2% and 4.1% of patients in the placebo, 100mg and 200mg groups, respectively.
“These initial Phase III data support the potential of filgotinib, in combination with select disease modifying drugs, to help patients with active rheumatoid arthritis who do not adequately respond to current biologic disease modifying agents,” said John McHutchison, chief scientific officer, head of R&D, at Gilead.
“These data are particularly encouraging as we look ahead to Phase III results from the ongoing FINCH 1 and 3 trials, which are exploring filgotinib in other populations of patients with rheumatoid arthritis.”