Oral JAK inhibitor Filgotinib treatment UC 2b/3 clinical to the main endpoint

The compilation of S.Lidays ago, Gilead and Galapagos jointly announced that the oral JAK inhibitor Filgotinib, jointly developed by the two companies, had achieved positive results in the 2b/3 clinical trial SELECTIONThis is a randomized, double-blind, placebo-controlled trial that assessed the effectiveness and safety of Filgotinib in 1,348 adult patients with moderate lysing ulcerative colitis (UC) who had been or were not treated with biologicsresults showed that the Filgotinib 200mg dose group reached all major endpoints of the study, and patients in the treatment group induced clinical remission at week 10 for a duration of 58 weeksAt week 10, however, the Filgotinib 100mg dose group did not achieve statistically significant clinical remissionspecific data were that in patients who did not receive biotherapy, the proportion of patients in the Filgotinib 200mg dose group achieving clinical remission was higher by the 10th week (26.1% VS.15.3%, p.0157) with statistical differencesIn patients treated with biologics, the proportion of patients in the Filgotinib 200mg dose group who achieved clinical remission by week 10 also had significant differences (11.5% VS.4.2%, p.0103)patients who achieved clinical remission after 10 weeks in the two dose-based treatment groups of Filgotinib, and were then reassigned to the Filgotinib group or placebo group in a 2:1 ratio, taking an induced therapeutic dose and continuing into the 58th week (maintenance trial, n-558)The results showed that both doses of Filgotinib reached the main endpoint of the maintenance testAt week 58, 37.2% of patients in the 200mg filgotinib group achieved clinical remission, compared with 11.2% in the placebo group (p.0.0001), and the Filgotinib 100mg treatment group achieved clinical remission at 23.8% in the 58th week and 13.5% of the placebo (p.0.0420)in this trial, clinical remission was defined as a score of 0 or 1 under the endoscope, 0 for rectal bleeding sub-items, and a decrease in fecal frequency from a baseline of .1 to 0 or 1Among patients who were not treated with biologics, 52% of patients had a Mayo Clinic score (MCS) baseline of 9 points and aboveOf the patients treated with biologics, 74% had an MCS baseline of 9 or more, and 51% had been treated with two different biologicagents (TNF alpha antagonists and protoprotein receptor antagonists)in induction trials, no deaths occurred in all treatment groups, and the incidence of severe adverse events was similar in patients without biological treatment (200mg: 1.2%; 100 mg: 4.7%; placebo: 2.9%), and in patients treated with biotherapy, the incidence of each dose group was similar to that of the placebo group (200mg: 7.3%; 100mg: 5.3%; placebo: 6.3%)In the maintenance trial, no drug-related deaths occurred, the proportion of severe adverse events in the Filgotinib 200mg treatment group was 4.5%, compared with the corresponding placebo groupThe proportion of severe adverse events in the Filgotinib 100mg treatment group was 4.5%, compared with 7.7% for the corresponding placeboDr Merdad Parsey, Chief Medical Officer, Gilead, said: "We were encouraged by the early reaction of Filgotinib as an induction therapy and its long-lasting efficacy as a maintenance therapy in the SELECTION trial These important data suggest that Filgotinib can help more patients achieve meaningful and long-lasting therapeutic responses through oral therapy "
UC and Crohn's disease (CD) are two of the most common inflammatory bowel diseases (IBDs), both chronic, recurrent, and self-relieving inflammatory progressive digestive diseases It is estimated that 40% of UC patients experience relapse each year without sustained remission Filgotinib, a drug developed by Gilead in collaboration with Galapagos, is currently being approved for NDA in adult patients with moderate to severe active rheumatoid arthritis in the U.S FDA and Japan's Ministry of Health, Labour and Welfare In addition to SELECTION, Filgotinib is conducting several clinical studies on inflammatory diseases, including the rheumatoid arthritis phase 3 trial FINCH, Crohn's Disease Phase 3 trial DIVERSITY, psoriasis arthritis phase 3 trial PENGUIN, and more