Gilead’s filgotinib may pass Phase III risk-benefit bar in RA with JAK-1 target despite safety caution; efficacy has more assurances, experts say

15 May 2018

(NASDAQ:GILD) GLPG0634 (filgotinib) for rheumatoid arthritis (RA) may see its more targeted mechanism offer safety advantages for its Phase III FINCH 2 trial, though reservations linger after Eli Lilly’s (NYSE:LLY) Olumiant (baricitinib) setbacks, experts said. They remain upbeat on the janus kinase 1 (JAK1) inhibitor’s potential to provide strong efficacy based on previous signals and comparisons to Pfizer’s (NYSE:PFE) approved drug in the same class, Xeljanz (tofacitinib).

Gilead -- in collaboration with Galapagos (AMS:GLPG) -- expects to release data in mid-2018. Analysts were positive on filgotinib’s potential to pull through, with its demonstrated activity, despite safety flags on RA drugs, and sales could reach USD 4bn. Gilead has a market cap of USD 85bn.

The company is investigating efficacy and safety in the six-month FINCH 2 trial (NCT02873936) in 432 patients who are on conventional disease-modifying antirheumatic drugs (cDMARDs) and had an inadequate response to biologics. The primary endpoint is ACR20 at week 12, according to ClinicalTrials.gov. First-line therapy for RA is methotrexate, followed by either an anti-TNF or more recently a JAK inhibitor like Xeljanz.

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