Gilead has announced that its investigational rheumatoid arthritis (RA) drug, filgotinib, has proved successful in a trial evaluating its efficacy and safety when treating moderately-to-severely active versions of the disease.
The oral, selective JAK1 inhibitor demonstrated durable efficacy and safety results across multiple RA patient populations, from MTX-naïve patients to those who have had an inadequate response to two or more biologic disease-modifying antirheumatic drugs.
The Phase III trial, dubbed FINCH 2, evaluated once-daily doses of both 200mg and 100mg in 449 patients who previously had an inadequate response to biologic therapy, and showed that both doses of filgotinib improved clinical outcomes versus placebo, regardless of the number and mechanism of action (MOA) of prior inadequate drug responses.
After 12 weeks of treatment, 70.3% of subjects treated with 200 mg of the therapy and 58.2% of subjects treated 100 mg achieved an ACR20 score, compared with only 25.7% of placebo-treated subjects. In addition, 68% of the 200 mg arm and 51.2% of the 100 mg patients achieved ACR20 response, compared to 27.35 of the placebo patients.
The data analysis “continue to demonstrate the consistent efficacy and safety profile of filgotinib for a broad range of patients, including those who have already tried other treatments and require other effective and tolerable options,” said John Sundy, senior vice president, inflammation and respiratory diseases.
He continued, “With the presentation of these results at the 2019 American College of Rheumatology meeting, we are one step closer in our journey to deliver upon the promise of filgotinib for patients in need.”
Galapagos and Gilead initially entered into a global collaboration for the development and commercialisation of the drug in inflammatory indications in 2015.