US antiviral drugmaker Gilead Sciences and Belgo-Dutch biotech Galapagos have announced week 52 data from the Phase III FINCH 1 and 3 trials of rheumatoid arthritis (RA) candidate filgotinib.
Discovered and developed by Galapagos, filgotinib is an oral, selective JAK1 inhibitor and an investigational agent from regulatory view.
In 2015, the two companies reached a global collaboration to develop and commercialise filgotinib in inflammatory indications.
The FINCH Phase III programme is designed to study filgotinib’s efficacy and safety. FINCH 1 and 3 are 52-week randomised studies.
The drug was administered in doses of 100mg and 200mg once daily in RA patients during the trials.
About 1,759 adult patients were enrolled in FINCH 1 trial who were suffering from moderately to severely active RA and had an inadequate response to methotrexate (MTX). FINCH 3 involved 1,252 MTX-naïve patients.
The week 52 data from the trials was consistent with and supported filgotinib’s efficacy, safety and tolerability profiles reported at weeks 12 and 24.
Galapagos chief medical officer Dr Walid Abi-Saab said: “These recent updates from the FINCH 1 and 3 trials continue to provide consistent evidence to support filgotinib’s profile in RA patients.
“In the second half of the FINCH 1 and FINCH 3 trials, filgotinib exhibited the same favourable safety profile seen in the first 24 weeks, including similar rates of thrombotic events as previously observed, as well as persistent efficacy.”
Earlier this week, Gilead filed a new drug application (NDA) for the approval of filgotinib to treat RA adults in Japan.
The filgotinib marketing authorisation application (MAA) filing is currently under review with the European Medicines Agency (EMA).
Gilead also has plans to file for US approval of filgotinib later this year.
Gilead Sciences Inflammation and Respiratory Diseases senior vice-president John Sundy said: “We are encouraged by the durability of both the efficacy and safety profiles of filgotinib seen in these studies.
“These data suggest that filgotinib if approved, may play an important role in helping people living with rheumatoid arthritis achieve sustained, clinically meaningful responses.”