Gilead Sciences and Galapagos have reported positive data from the Phase III FINCH 1 and FINCH 3 clinical trials of filgotinib in adults with moderately to severely active rheumatoid arthritis (RA).
Results showed sustained efficacy and a consistent safety profile up to 52 weeks.
The FINCH 1 study compared filgotinib to placebo or adalimumab on a stable background methotrexate dose in patients who previously experienced an inadequate response to methotrexate.
Patients received filgotinib 200mg once daily, 100mg once daily, adalimumab 40mg bi-weekly, or matching placebo.
Data demonstrated that filgotinib 200mg met the primary study endpoint with a higher proportion of patients achieving at least a 20% improvement in the number of tender and swollen joints at week 12 compared to placebo.
The drug was also superior to placebo on all secondary endpoints of signs and symptoms of RA, physical function, and structural damage.
At 52 weeks, both doses of the drug demonstrated sustained efficacy in primary and secondary outcome measures. The safety profile was also consistent, without any new signals through week 52.
Meanwhile, the FINCH III trial assessed filgotinib in patients naïve to methotrexate.
Patients received filgotinib 200mg plus methotrexate, filgotinib 100mg plus methotrexate, filgotinib 200mg monotherapy and methotrexate monotherapy.
This study also met the primary study endpoint of the proportion of patients achieving ACR20 at week 24 compared to methotrexate alone. All treatment groups showed sustained efficacy to week 52, Gilead added.
Gilead Sciences Inflammation senior vice-president Mark Genovese said: “Many people with RA struggle with uncontrolled symptoms that affect their daily lives. We are working to develop effective and well-tolerated treatment options that will make a difference in the lives of patients.
“These data add to the body of evidence supporting filgotinib as a potential treatment option for a range of RA patients.”
Gilead and Galapagos partnered for the global development and commercialisation of filgotinib in RA and other inflammatory indications.