Galapagos NV has reported 20-week results from its FITZROY study with the investigational, selective JAK1 inhibitor filgotinib in Crohn’s disease. 174 patients with moderately to severely active Crohn’s disease were enrolled in FITZROY, a double-blind, placebo-controlled Phase 2 study. Patients recruited were either anti-TNF naïve or anti-TNF failures.
The study comprised two parts each of 10 weeks duration: the first part – reported in December 2015 - investigated the safety and efficacy of filgotinib 200 mg once daily versus placebo. The FITZROY study achieved the primary endpoint of clinical remission at 10 weeks: the percentage of patients achieving a Crohn’s Disease Activity Index (CDAI) score lower than 150 was significantly higher in patients treated with filgotinib versus patients receiving placebo.
Improvement in histopathology and endoscopy assessments were observed at Week 10. Further evaluation is ongoing. The second part of the study investigated continued treatment through 20 weeks in an exploratory analysis that was not powered for statistical significance. Clinical responses continued from week 10 to week 20. Non-responders in the placebo arm from the first ten weeks received filgotinib 100 mg in the second ten weeks and showed improvement in clinical remission during the second part of the study.
There were no new safety signals during the second part of the FITZROY study, consistent with the profile of filgotinib previously described. Most common adverse events observed during this study were infections, gastrointestinal disorders and nervous system disorders. There were no gastrointestinal perforations, no cancers and no deaths reported during the study. Galapagos and Gilead Sciences intend to submit the FITZROY 20-week results to future medical conferences.
"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,” said Piet Wigerinck, Chief Scientific Officer at Galapagos. “We are proud to be advancing what could become the first new oral treatment for Crohn’s disease in decades.”
Galapagos and Gilead entered into a global partnership for the development and commercialization of filgotinib for inflammatory indications. Gilead intends to initiate a Phase 3 study with filgotinib in Crohn’s disease later in 2016.