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FITZROY: Crohn’s patients maintain clinical response with filgotinib
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Additional data from the phase 2 FITZROY study showed patients with Crohn’s disease experienced continued clinical response with filgotinib through 20 weeks, according to a press release from the manufacturer.
Filgotinib (Galapagos) is an oral, selective Janus kinase 1 (JAK1) inhibitor that has previously shown efficacy in patients with rheumatoid arthritis in the DARWIN trials.
FITZROY is a double-blind, placebo-controlled trial involving 174 patients with moderately to severely active Crohn’s disease who either failed or were naive to anti-TNF therapy. The first 10-week part of the study, which was recently presented at the ECCO congress, evaluated the safety and efficacy of 200 mg, once-daily filgotinib vs. placebo. The primary endpoint of clinical remission at 10 weeks was achieved, with a significantly higher proportion of the filgotinib group achieving a CDAI score lower than 150. Patients also showed histopathologic and endoscopic improvement at week 10.
The second part of the study was an exploratory analysis of continued treatment through 20 weeks, which was not powered for statistical significance, according to the press release. Clinical responses continued from weeks 10 through 20, and nonresponders who received placebo in the first part of the study and received 100 mg filgotinib in the second part experienced improvements in clinical remission. Moreover, no new safety signals were observed, no GI perforations, cancers or deaths occurred, and the most common adverse events were infections, GI disorders and nervous system disorders.
“We are pleased by the outcome of the FITZROY study, positioning filgotinib as a potential oral treatment for patients with Crohn’s disease. The observed safety profile of filgotinib further strengthens its promising efficacy,” Piet Wigerinck, PhD, chief scientific officer at Galapagos said in the press release. “We are proud to be advancing what could become the first new oral treatment for Crohn’s disease in decades.”
Galapagos and Gilead have partnered to develop and commercialize filgotinib for inflammatory indications, and plan to submit the additional FITZROY data to medical conferences for presentation in the future, according to the press release. Gilead also plans to begin a phase 3 trial of filgotinib in Crohn’s disease later this year.
Disclosure: Wigerinck is employed by Galapagos.