Gilead, Galapagos' experimental drug filgotinib hits main goal of Phase III study in rheumatoid arthritis

Gilead Sciences and Galapagos reported Tuesday that the investigational JAK1 inhibitor filgotinib achieved the primary endpoint of the FINCH 2 late-stage study involving adults with moderately-to-severely active rheumatoid arthritis who had an inadequate response or intolerance to prior biologic agents. Gilead chief scientific officer John McHutchison remarked "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."  

In the FINCH 2 study, adults with moderately-to-severely active rheumatoid arthritis who had not respond adequately to biologic disease-modifying anti-rheumatic drugs were randomly assigned to treatment with filgotinib, at a dose of 100 mg or 200 mg, or placebo for 24 weeks. The primary endpoint of the study was the percentage of patients achieving an American College of Rheumatology 20 percent response (ACR20) at 12 weeks, while secondary endpoints included the proportions of patients with ACR50, ACR70, low disease activity and clinical remission at 12 and 24 weeks.  

Results showed that 57.5 percent and 66 percent of patients in the low and high filgotinib dose groups, respectively, achieved ACR20 at 12 weeks, versus 31.1 percent for placebo. Additionally, the proportions of patients with ACR50 at 12 weeks in the low and high dose groups of filgotinib were 32 percent and 42.9 percent respectively, compared to 14.9 percent for placebo, while 14.4 percent and 21.8 percent of patients in the low and high filgotinib dose groups, respectively, achieved ACR70, versus 6.8 percent of placebo-treated patients.  

Meanwhile, according to the drugmakers, low disease activity was found in 37.3 percent and 40.8 percent of patients who received the low and high dose of filgotinib, respectively, compared to 15.5 percent for the placebo group. Regarding clinical remission, the rates in the low and high filgotinib dose groups were 25.5 percent and 22.4 percent, respectively, versus 8.1 percent in the placebo arm. 

The drugmakers noted that the therapy was generally well-tolerated with no new safety signals identified. The companies added that detailed results from the study will be submitted for presentation at a future research conference. Commenting on the new findings, Jefferies analyst Peter Welford said filgotinib's efficacy was on a par or above rivals, whilst also offering a potentially superior safety profile. Welford suggested that the drug could generate peak global sales of $6 billion, with half coming from rheumatoid arthritis, while Berenberg analysts peg revenue at $4 billion.

In 2015, Gilead inked a deal with Galapagos potentially worth more than $2 billion to jointly develop filgotinib for inflammatory conditions. AbbVie had previously returned the rights to the therapy to Galapagos after declining to exercise an option. Earlier this month, Gilead and Galapagos announced that a Phase II study of filgotinib in adults with moderately-to-severely active ankylosing spondylitis met its primary efficacy endpoint.

For related analysis, see ViewPoints: Gilead and Galapagos stay the course with latest filgotinib update. See also, ViewPoints: AS data the entrée for filgotinib with key Phase III results imminent.

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