Gilead and Galapagos's filgotinib shows sustained efficacy in ulcerative colitis study
Oct. 12, 2020 10:30 AM ET|About: Gilead Sciences, Inc. (GILD)|By: Vandana Singh, SA News Editor
Additional data from Phase 2b/3 Selection trial evaluating filgotinib in 1,348 biologic-naïve or biologic-experienced for the treatment of moderate to severe active ulcerative colitis (UC) patients, demonstrated sustained efficacy and safety. Results were presented at the 2020 United European Gastroenterology Week Virtual Meeting.
Gilead Sciences (GILD +0.3%) and Galapagos (GLPG +1.2%) have collaborated for the development filgotinib, an oral, once-daily, JAK1 preferential inhibitor.
Data showed that a significantly higher proportion of patients treated with filgotinib 200 mg, versus placebo, achieved clinical remission at Week 10 (26.1% vs. 15.3%).
Additionally, 24.5% of the patients treated with filgotinib 200 mg achieved Mayo Clinic Score remission, vs. 12.4% on placebo, endoscopic remission was seen in 12.2% of patients vs. 3.6% and histologic remission of 35.1% vs. 16.1%.
At Week 58, 37.2% of patients receiving filgotinib 200 mg achieved clinical remission, compared with 11.2% on placebo. Sustained clinical remission was observed at 18.1% vs. 5.1% placebo.
Also, 27.2% of patients treated with filgotinib 200 mg achieved six-month corticosteroid-free clinical remission at Week 58 compared with 6.4% in placebo.
On the safety front, incidence of adverse events (AE), serious AEs and discontinuations due to AEs were similar in the filgotinib and placebo groups in both the induction and maintenance periods of the study.
Most common adverse events of serious infections, herpes zoster, venous thrombosis, pulmonary embolism and gastrointestinal perforation, were observed.
Two deaths were observed in the filgotinib 200 mg maintenance arm, though those were considered unrelated to study drug, by the investigators.
Earlier in May, the companies announced that the study met the primary endpoints of statistically significant proportions of treated patients achieving remission at week 10 and maintaining remission at week 58, both compared to placebo.