Gilead Sciences and Galapagos NV’s Phase 2 EQUATOR study of filgotinib, an investigational, selective JAK1 inhibitor, has achieved its primary endpoint of improvement in the signs and symptoms of psoriatic arthritis in 131 adults.
Gilead said in its press release that Filgotinib was generally well-tolerated in the EQUATOR trial, with no new safety signals observed and similar laboratory changes compared to those reported in previous trials with filgotinib in rheumatoid arthritis patients. The adverse event rate was similar in both groups with mostly mild or moderate events reported. There was one serious infection in the filgotinib group, a patient who experienced pneumonia with a fatal outcome. One other patient receiving filgotinib developed herpes zoster. There were no cases of opportunistic infection, tuberculosis, thromboembolism, or malignancy, the company said.
Dr. Philip Mease, from the University of Washington, Seattle, said that the data from the Equator study were impressive and indicate that filgotinib has the potential to have a significant effect on signs and symptoms of psoriatic arthritis, a condition where there is still a high unmet medical need.
“We are pleased to report that filgotinib remains consistent in terms of activity and tolerability, now also in psoriatic arthritis,” said Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos.
Separately, Gilead and Galapagos also announced that an independent Data Monitoring Committee (DMC) conducted a planned interim futility analysis of the filgotinib Phase 2b/3 ulcerative colitis study, SELECTION, after 350 patients completed the induction period in the Phase 2b portion of the study. The DMC recommended that the study proceed into Phase 3 as planned at both the 100 mg and 200 mg once daily dose level in biologic-experienced and biologic-naïve patients.
Galapagos to cash in $15 million
Galapagos is to receive a $15 million payment from Gilead for this progression from Phase 2 to Phase 3 in the SELECTION trial.
John McHutchison, Chief Scientific Officer, Head of Research and Development, Gilead said: “We continue to see great potential with filgotinib to treat a range of inflammatory diseases. As such, we are pleased with the continued progress of the development programs, including the EQUATOR results and advancing the SELECTION study into Phase 3.”